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Protocol summary
Determining and comparing the effect of two drug regimens noradrenaline plus Milrinone versus noradrenaliene plus dobutamine`s effect on adult`s pulmonary hypertension after heart valve implantation.
Determining and comparing the effect of Milrinone and dobutamine on adult`s pulmonary hypertension after heart valve replacement surgery
Determining and comparing the effect of two drug regimens noradrenaline plus Milrinone versus noradrenaliene plusand dobutamine`s effect on adult`s pulmonary hypertension after heart valve implantation.replacement surgery
تعیین و مقایسه تاثیر دو رژیم دارویی نورآدرنالین همراه میلرینون با نورآدرنالین همراه دوبوتامین بر هایپرتنشن ریوی بعد از اعمال جراحی تعویض دریچه قلب بالغین
تعیین و مقایسه تاثیر دو داروی میلرینون و دوبوتامین بر هایپرتنشن ریوی، بعد از اعمال جراحی تعویض دریچه قلب بالغین
تعیین و مقایسه تاثیر دو رژیم دارویی نورآدرنالین همراهداروی میلرینون با نورآدرنالین همراهو دوبوتامین بر هایپرتنشن ریوی، بعد از اعمال جراحی تعویض دریچه قلب بالغین
In this study,38 patients suffering pulmonary hypertension who are candidates for heart valve replacement surgery in isfahan Shahid Chamran Heart hospital are randomly divided into two groups receiving milrinone + noradrenaline (group 1) and dobutamine + noradrenaline (group 2) using random allocation software. Systolic pulmonary arterial pressure (SPAP), Mean pulmonary arterial pressure (MPAP) and diastolic pulmonary arterial pressure (DPAP) are determined using echocardiography before surgery, then by implanting a pulmonary artery catheter، the above parameters are measured and recorded at the times after induction of anesthesia before Cardiopulmonary Bypass (CPB), after CPB, time to enter the Intensive care units(ICU) ،every 6 hours till 24 hours in the ICU and furthermore other parameters at the specific times.
In this study,38 patients suffering pulmonary hypertension who are candidates for heart valve replacement surgery in isfahan Shahid Chamran Heart hospital are randomly divided into two groups receiving milrinone (group 1) and dobutamine (group 2) using random allocation software. Systolic pulmonary arterial pressure (SPAP), Mean pulmonary arterial pressure (MPAP) and diastolic pulmonary arterial pressure (DPAP) are determined using echocardiography before surgery, then by implanting a pulmonary artery catheter، the above parameters are measured and recorded at the times after induction of anesthesia before Cardiopulmonary Bypass (CPB), after CPB, time to enter the Intensive care units(ICU) ،every 6 hours till 24 hours in the ICU and furthermore other parameters at the specific times.
In this study,38 patients suffering pulmonary hypertension who are candidates for heart valve replacement surgery in isfahan Shahid Chamran Heart hospital are randomly divided into two groups receiving milrinone + noradrenaline (group 1) and dobutamine + noradrenaline (group 2) using random allocation software. Systolic pulmonary arterial pressure (SPAP), Mean pulmonary arterial pressure (MPAP) and diastolic pulmonary arterial pressure (DPAP) are determined using echocardiography before surgery, then by implanting a pulmonary artery catheter، the above parameters are measured and recorded at the times after induction of anesthesia before Cardiopulmonary Bypass (CPB), after CPB, time to enter the Intensive care units(ICU) ،every 6 hours till 24 hours in the ICU and furthermore other parameters at the specific times.
در این پژوهش 38 مورد از بیمارانی که از بیماران بالغ مبتلا به هایپرتنشن ریوی که کاندید عمل جراحی تعویض دریچه قلب در بیمارستان قلب شهید چمران اصفهان هستند با استفاده از نرم افزار random allocation بصورت تصادفی در دو گروه دریافت کننده میلرینون+نورآدرنالین(گروه 1) و دوبوتامین+نورآدرنالین(گروه2) قرار میگیرند و ابتدا پیش از عمل جراحی با استفاده از اکو 3 مقدار systolic pulmonary arterial pressure (SPAP) و Mean pulmonary arterial pressure (MPAP) و diastolic pulmonary arterial pressure (DPAP) تعیین میگردد ، سپس با تعبیه یک pulmonary artery catheter این 3 پارامتر فوق را در زمان های بعد از القای بیهوشی قبل از Cardiopulmonary Bypass (CPB) ، بعد از CPB، زمان وروئ بهIntensive Care Units (ICU)هر 6 ساعت تا 24 ساعت در ICU وسایر پرامتر ها در زمان های مشخص اندازه گیری شده و ثبت میشود.
در این پژوهش 38 مورد از بیمارانی که از بیماران بالغ مبتلا به هایپرتنشن ریوی که کاندید عمل جراحی تعویض دریچه قلب در بیمارستان قلب شهید چمران اصفهان هستند با استفاده از نرم افزار random allocation بصورت تصادفی در دو گروه دریافت کننده میلرینون(گروه 1) و دوبوتامین(گروه2) قرار میگیرند و ابتدا پیش از عمل جراحی با استفاده از اکو 3 مقدار systolic pulmonary arterial pressure (SPAP) و Mean pulmonary arterial pressure (MPAP) و diastolic pulmonary arterial pressure (DPAP) تعیین میگردد ، سپس با تعبیه یک pulmonary artery catheter این 3 پارامتر فوق را در زمان های بعد از القای بیهوشی قبل از Cardiopulmonary Bypass (CPB) ، بعد از CPB، زمان وروئ بهIntensive Care Units (ICU)هر 6 ساعت تا 24 ساعت در ICU وسایر پرامتر ها در زمان های مشخص اندازه گیری شده و ثبت میشود.
در این پژوهش 38 مورد از بیمارانی که از بیماران بالغ مبتلا به هایپرتنشن ریوی که کاندید عمل جراحی تعویض دریچه قلب در بیمارستان قلب شهید چمران اصفهان هستند با استفاده از نرم افزار random allocation بصورت تصادفی در دو گروه دریافت کننده میلرینون+نورآدرنالین(گروهمیلرینون(گروه 1) و دوبوتامین+نورآدرنالین(گروه2دوبوتامین(گروه2) قرار میگیرند و ابتدا پیش از عمل جراحی با استفاده از اکو 3 مقدار systolic pulmonary arterial pressure (SPAP) و Mean pulmonary arterial pressure (MPAP) و diastolic pulmonary arterial pressure (DPAP) تعیین میگردد ، سپس با تعبیه یک pulmonary artery catheter این 3 پارامتر فوق را در زمان های بعد از القای بیهوشی قبل از Cardiopulmonary Bypass (CPB) ، بعد از CPB، زمان وروئ بهIntensive Care Units (ICU)هر 6 ساعت تا 24 ساعت در ICU وسایر پرامتر ها در زمان های مشخص اندازه گیری شده و ثبت میشود.
The group that receiving noradrenaline with milrinone and the group that receiving noradrenaline with dobutamine
The group that receiving milrinone infusion at a dose of 0.5 - 0.75 μg/kg/min and the group that receiving dobutamine 5-10 μg/kg/min infusion during 3 days of ICU hospitalization after surgery
The group that receiving noradrenaline with milrinone infusion at a dose of 0.5 - 0.75 μg/kg/min and the group that receiving noradrenaline with dobutamine 5-10 μg/kg/min infusion during 3 days of ICU hospitalization after surgery
گروه دریافت کننده رژیم دارویی نورآدرنالین به همراه میلرینون و گروه دریافت کننده رژیم دارویینورآدرنالین همراه دوبوتامین
گروه دریافت کننده انفوزیون داروی میلرینون با دوز μg/kg/min 0.5 - 0.75 و گروه دریافت کننده انفوزیون داروی دوبوتامین μg/kg/min 10-5 در طی 3 روز بستری در ICU پس از جراحی
گروه دریافت کننده رژیم دارویی نورآدرنالین به همراهانفوزیون داروی میلرینون با دوز μg/kg/min 0.5 - 0.75 و گروه دریافت کننده رژیم دارویینورآدرنالین همراهانفوزیون داروی دوبوتامین μg/kg/min 10-5 در طی 3 روز بستری در ICU پس از جراحی
General information
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Hemodynamics of patients were maintained with the two main drugs of the study (milrinone and dobutamine), and because of professional and ethical reasons there was no need to use adjuvant and Additional drugs in most cases, so the title of the study is summarized as follows.
Hemodynamics of patients were maintained with the two main drugs of the study (milrinone and dobutamine), and because of professional and ethical reasons there was no need to use adjuvant and Additional drugs in most cases, so the title of the study is summarized as follows.
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در بیماران با دو داروی اصلی مطالعه (میلرینون و دوبوتامین) همودینامیک بیماران حفظ شد و به دلایل حرفه و اخلاقی نیازی به استفاده از داروی کمکی و اضافی در اغلب موارد نبود لذا عنوان مطالعه بدین شکل تلخیص شده است.
در بیماران با دو داروی اصلی مطالعه (میلرینون و دوبوتامین) همودینامیک بیماران حفظ شد و به دلایل حرفه و اخلاقی نیازی به استفاده از داروی کمکی و اضافی در اغلب موارد نبود لذا عنوان مطالعه بدین شکل تلخیص شده است.
Comparison of the effect of two drug regimens of noradrenaline plus milrinone and noradrenaline plus dobutamine on pulmonary hypertension
Comparison of the effect of milrinone and dobutamine on pulmonary hypertension
Comparison of the effect of two drug regimens of noradrenaline plus milrinone and noradrenaline plus dobutamine on pulmonary hypertension
مقایسه ی تاثیر دو رژیم دارویی نورآدرنالین همراه میلرینون با نورآدرنالین همراه دوبوتامین بر هایپرتنشن ریوی
مقایسه ی تاثیر دو داروی میلرینون و دوبوتامین بر هایپرتنشن ریوی
مقایسه ی تاثیر دو رژیم دارویی نورآدرنالین همراهداروی میلرینون با نورآدرنالین همراهو دوبوتامین بر هایپرتنشن ریوی
Comparative evaluation between two drug regimens Noradrenaline plus Milrinone versus Noradrenaliene plus Dobutamine`s effect on adult`s pulmonary hypertension after heart valve implantation.
Comparative study of the effect of milrinone and dobutamine on pulmonary hypertension after adult heart valve replacement surgery
Comparative evaluation between two drug regimens Noradrenaline plus Milrinone versus Noradrenaliene plus Dobutamine`sstudy of the effect of milrinone and dobutamine on adult`s pulmonary hypertension after adult heart valve implantation.replacement surgery
بررسی مقایسه ای تاثیر دو رژیم دارویی نورآدرنالین همراه میلرینون با نورآدرنالین همراه دوبوتامین بر هایپرتنشن ریوی بعد از اعمال جراحی تعویض دریچه قلب بالغین
بررسی مقایسه ای تاثیر دو داروی میلرینون و دوبوتامین بر هایپرتنشن ریوی، بعد از اعمال جراحی تعویض دریچه قلب بالغین
بررسی مقایسه ای تاثیر دو رژیم دارویی نورآدرنالین همراهداروی میلرینون با نورآدرنالین همراهو دوبوتامین بر هایپرتنشن ریوی، بعد از اعمال جراحی تعویض دریچه قلب بالغین
Intervention groups
#1
Intervention group 1:The group that receiving Intravenous infusion of noradrenaline at a dose of 0.1 - 0.5 μg / kg / min with milrinone at a dose of 0.5 - 0.75 μg / kg / min. Medication regimens commence from the time of patient`s rewarming and continue until the patient's condition stabilizes in the Intensive Care Unit under the anesthesia attending`s care .Milrinone is a phosphodiesterase III inhibitor commonly used after cardiopulmonary bypass in combination with adrenaline or noradrenaline to reduce pulmonary artery pressure with a synergistic inotropic effect. Noradrenaline made by BCWORLD PHARM CO. South Korea and Milrinon made by Baxter India.
Intervention group 1:The group that receiving Intravenous infusion of milrinone at a dose of 0.5 - 0.75 μg / kg / min. Medication regimens commence from the time of patient`s rewarming and continue until the patient's condition stabilizes in the Intensive Care Unit under the anesthesia attending`s care .Milrinone is a phosphodiesterase III inhibitor commonly used after cardiopulmonary bypass in combination with adrenaline or noradrenaline μg/kg/min 0.1 - 0.5 to reduce pulmonary artery pressure with a synergistic inotropic effect. Noradrenaline made by BCWORLD PHARM CO. South Korea and Milrinon made by Baxter India.
Intervention group 1:The group that receiving Intravenous infusion of noradrenaline at a dose of 0.1 - 0.5 μg / kg / min with milrinone at a dose of 0.5 - 0.75 μg / kg / min. Medication regimens commence from the time of patient`s rewarming and continue until the patient's condition stabilizes in the Intensive Care Unit under the anesthesia attending`s care .Milrinone is a phosphodiesterase III inhibitor commonly used after cardiopulmonary bypass in combination with adrenaline or noradrenaline μg/kg/min 0.1 - 0.5 to reduce pulmonary artery pressure with a synergistic inotropic effect. Noradrenaline made by BCWORLD PHARM CO. South Korea and Milrinon made by Baxter India.
گروه مداخله 1: گروه دریافت کننده ی انفوزیون وریدی رژیم دارویی نورآدرنالین با دوزμg/kg/min 0.1 - 0.5 به همراه میلرینون با دوز μg/kg/min 0.5 - 0.75 .رژیم های دارویی از زمان rewarming مریض شروع شده و تا پایدار شدن شرایط بیمار در Intensive Care Units تحت نظر اتندینگ بیهوشی ادامه میابند.میلرینون یک phosphodiesterase III inhibitor است که به طور شایع پس از بایپس قلبی ریوی در ترکیب با آدرنالین یا نورآدرنالین به منظور کاهش دادن فشار شریان ریوی با اثر اینوتروپیک سینرژیک استفاده میشود. داروی نورآدرنالین محصول کمپانی BCWORLD PHARM CO. کره جنوبی و داروی میلرینون محصول کمپانی باکستر هند میباشد.
گروه مداخله 1: گروه دریافت کننده ی انفوزیون وریدی داروی میلرینون با دوز μg/kg/min 0.5 - 0.75 .رژیم های دارویی از زمان rewarming مریض شروع شده و تا پایدار شدن شرایط بیمار در Intensive Care Units تحت نظر اتندینگ بیهوشی ادامه میابند.میلرینون یک phosphodiesterase III inhibitor است که به طور شایع پس از بایپس قلبی ریوی در ترکیب با آدرنالین یا نورآدرنالینμg/kg/min 0.1 - 0.5 به منظور کاهش دادن فشار شریان ریوی با اثر اینوتروپیک سینرژیک استفاده میشود. داروی نورآدرنالین محصول کمپانی BCWORLD PHARM CO. کره جنوبی و داروی میلرینون محصول کمپانی باکستر هند میباشد.
گروه مداخله 1: گروه دریافت کننده ی انفوزیون وریدی رژیم دارویی نورآدرنالین با دوزμg/kg/min 0.1 - 0.5 به همراهداروی میلرینون با دوز μg/kg/min 0.5 - 0.75 .رژیم های دارویی از زمان rewarming مریض شروع شده و تا پایدار شدن شرایط بیمار در Intensive Care Units تحت نظر اتندینگ بیهوشی ادامه میابند.میلرینون یک phosphodiesterase III inhibitor است که به طور شایع پس از بایپس قلبی ریوی در ترکیب با آدرنالین یا نورآدرنالیننورآدرنالینμg/kg/min 0.1 - 0.5 به منظور کاهش دادن فشار شریان ریوی با اثر اینوتروپیک سینرژیک استفاده میشود. داروی نورآدرنالین محصول کمپانی BCWORLD PHARM CO. کره جنوبی و داروی میلرینون محصول کمپانی باکستر هند میباشد.
#2
Intervention group 2: The groupe that receiving Intravenous infusion of noradrenaline 0.1-0.5 μg / kg / min with dobutamine 5-10 μg / kg / min. Dubotamine through strong agonist stimulation effect on Bradykinin 1 Receptor and moderate stimulation effect on Bradykinin 2 Receptor increases myocardial contractility and increases stroke volume, cardiac output and heart rate and decreases vascular resistance. After cardiac surgery, the combined use of dobutamine with Noradrenaline has a double inotropic effect due to its competitive effect on Bradykinin 1 Receptor. Noradrenaline made by BCWORLD PHARM CO. South Korea and Dobutamine made by Darou Paksh- Iran.
Intervention group 2: The groupe that receiving Intravenous infusion of dobutamine 5-10 μg / kg / min. Dubotamine through strong agonist stimulation effect on Bradykinin 1 Receptor and moderate stimulation effect on Bradykinin 2 Receptor increases myocardial contractility and increases stroke volume, cardiac output and heart rate and decreases vascular resistance. After cardiac surgery, the combined use of dobutamine with Noradrenaline μg/kg/min 0.1 - 0.5 has more inotropic effect due to its competitive effect on Bradykinin 1 Receptor.Noradrenaline made by BCWORLD PHARM CO. South Korea and Dobutamine made by Darou Paksh- Iran.
Intervention group 2: The groupe that receiving Intravenous infusion of noradrenaline 0.1-0.5 μg / kg / min with dobutamine 5-10 μg / kg / min. Dubotamine through strong agonist stimulation effect on Bradykinin 1 Receptor and moderate stimulation effect on Bradykinin 2 Receptor increases myocardial contractility and increases stroke volume, cardiac output and heart rate and decreases vascular resistance. After cardiac surgery, the combined use of dobutamine with Noradrenaline μg/kg/min 0.1 - 0.5 has a doublemore inotropic effect due to its competitive effect on Bradykinin 1 Receptor. NoradrenalineReceptor.Noradrenaline made by BCWORLD PHARM CO. South Korea and Dobutamine made by Darou Paksh- Iran.
گروه مداخله 2: دریافت کننده ی انفوزیون وریدی رژیم دارویی نورآدرنالین0.1 μg/kg/min 0.5- به همراه دوبوتامین μg/kg/min10-5 . دوبوتامین از طریق تحریک آگونیستی قوی Bradykinin 1 Receptor و تحریک متوسط Bradykinin 2 Receptor به قدرت انقباضی میوکارد قلب می افزاید و باعث افزایش حجم ضربه ای ، برون ده قلبی و ضربان قلب و کاهش مقاومت عروق میشود پس از جراحی قلب استفاده ی ترکیبی دوبوتامین به همراه نورآدرنالین به علت اثر رقابتی بر Bradykinin 1 Receptor اثر اینوتروپیک مضاعفی ایجاد میکند. داروی نورآدرنالین محصول کمپانی BCWORLD PHARM CO. کره جنوبی و داروی دوبوتامین محصول کمپانی داروپخش ایران میباشد.
گروه مداخله 2: دریافت کننده ی انفوزیون وریدی داروی دوبوتامین μg/kg/min10-5 . دوبوتامین از طریق تحریک آگونیستی قوی Bradykinin 1 Receptor و تحریک متوسط Bradykinin 2 Receptor به قدرت انقباضی میوکارد قلب می افزاید و باعث افزایش حجم ضربه ای ، برون ده قلبی و ضربان قلب و کاهش مقاومت عروق میشود پس از جراحی قلب استفاده ی ترکیبی دوبوتامین به همراه نورآدرنالین μg/kg/min 0.1 - 0.5 به علت اثر رقابتی بر Bradykinin 1 Receptor اثر اینوتروپیک مضاعفی ایجاد میکند. داروی نورآدرنالین محصول کمپانی BCWORLD PHARM CO. کره جنوبی و داروی دوبوتامین محصول کمپانی داروپخش ایران میباشد.
گروه مداخله 2: دریافت کننده ی انفوزیون وریدی رژیم دارویی نورآدرنالین0.1 μg/kg/min 0.5- به همراهداروی دوبوتامین μg/kg/min10-5 . دوبوتامین از طریق تحریک آگونیستی قوی Bradykinin 1 Receptor و تحریک متوسط Bradykinin 2 Receptor به قدرت انقباضی میوکارد قلب می افزاید و باعث افزایش حجم ضربه ای ، برون ده قلبی و ضربان قلب و کاهش مقاومت عروق میشود پس از جراحی قلب استفاده ی ترکیبی دوبوتامین به همراه نورآدرنالین μg/kg/min 0.1 - 0.5 به علت اثر رقابتی بر Bradykinin 1 Receptor اثر اینوتروپیک مضاعفی ایجاد میکند. داروی نورآدرنالین محصول کمپانی BCWORLD PHARM CO. کره جنوبی و داروی دوبوتامین محصول کمپانی داروپخش ایران میباشد.
Recruitment centers
#1
Name of recruitment center - English: Shahid Chamran Heart Educational, Medical and Research Center
Name of recruitment center - Persian: مرکز آموزشی ، درمانی و پژوهشی قلب شهید چمران
Full name of responsible person - English: mohammadreza shafiei
Full name of responsible person - Persian: محمدرضا شفیعی
Street address - English: 2nd Moshtagh St ,Isfahan , Isfahan Province
Street address - Persian: اصفهان ، خیابان مشتاق دوم
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8166173414
Phone: +98 31 3260 0961
Fax:
Email: dean@med.mui.ac.ir
Web page address:
Name of recruitment center - English: Shahid Chamran Heart Educational, Medical and Research Center
Name of recruitment center - Persian: مرکز آموزشی ، درمانی و پژوهشی قلب شهید چمران
Full name of responsible person - English: Mohammadreza Shafiei
Full name of responsible person - Persian: محمدرضا شفیعی
Street address - English: 2nd Moshtagh St ,Isfahan , Isfahan Province
Street address - Persian: اصفهان ، خیابان مشتاق دوم
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8166173414
Phone: +98 31 3260 0961
Fax:
Email: Dean@med.mui.ac.ir
Web page address:
Name of recruitment center - English: Shahid Chamran Heart Educational, Medical and Research Center Name of recruitment center - Persian: مرکز آموزشی ، درمانی و پژوهشی قلب شهید چمران Full name of responsible person - English: mohammadreza shafieiMohammadreza Shafiei Full name of responsible person - Persian: محمدرضا شفیعی Street address - English: 2nd Moshtagh St ,Isfahan , Isfahan Province Street address - Persian: اصفهان ، خیابان مشتاق دوم City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8166173414 Phone: +98 31 3260 0961 Fax: Email: deanDean@med.mui.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: dr mansour siavash dasjerdi
Full name of responsible person - Persian: دکتر منصور سیاوش دستجردی
Street address - English: hezar jerib avenue, isfahan
Street address - Persian: اصفهان خیابان هزارجریب
City - English: isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3668 0048
Fax:
Email: dean@med.mui.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Mansour Siavash Dasjerdi
Full name of responsible person - Persian: دکتر منصور سیاوش دستجردی
Street address - English: Hezar Jerib Avenue, Isfahan
Street address - Persian: اصفهان خیابان هزارجریب
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3668 0048
Fax:
Email: Dean@med.mui.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: dr mansour siavash dasjerdiDr Mansour Siavash Dasjerdi Full name of responsible person - Persian: دکتر منصور سیاوش دستجردی Street address - English: hezar jerib avenueHezar Jerib Avenue, isfahanIsfahan Street address - Persian: اصفهان خیابان هزارجریب City - English: isfahanIsfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8174673461 Phone: +98 31 3668 0048 Fax: Email: deanDean@med.mui.ac.ir Web page address:
Protocol summary
Study aim
Determining and comparing the effect of Milrinone and dobutamine on adult`s pulmonary hypertension after heart valve replacement surgery
Design
Clinical trial, consisting of two parallel groups receiving two different drug regimens, triple blinded, sample size of 38 patients, phase 3, randomized using random allocation software
Settings and conduct
In this study,38 patients suffering pulmonary hypertension who are candidates for heart valve replacement surgery in isfahan Shahid Chamran Heart hospital are randomly divided into two groups receiving milrinone (group 1) and dobutamine (group 2) using random allocation software. Systolic pulmonary arterial pressure (SPAP), Mean pulmonary arterial pressure (MPAP) and diastolic pulmonary arterial pressure (DPAP) are determined using echocardiography before surgery, then by implanting a pulmonary artery catheter، the above parameters are measured and recorded at the times after induction of anesthesia before Cardiopulmonary Bypass (CPB), after CPB, time to enter the Intensive care units(ICU) ،every 6 hours till 24 hours in the ICU and furthermore other parameters at the specific times.
Participants/Inclusion and exclusion criteria
Patients who are candidate for heart valve transplantation and suffering pulmonary hypertension
The age over 18 years old
The consent of patient to being involved
;
Renal and hepatic failure
Emergent surgery
necessity to inotropic drugs before surgery
Long QT interval patients
Drug allergy
Intervention groups
The group that receiving milrinone infusion at a dose of 0.5 - 0.75 μg/kg/min and the group that receiving dobutamine 5-10 μg/kg/min infusion during 3 days of ICU hospitalization after surgery
Main outcome variables
Reduction of pulmonary hypertension, reduction of mechanical respiration, reduction of inotropic drug using duration, reduction of ICU hospitalization, reduction of tachycardia
General information
Reason for update
Hemodynamics of patients were maintained with the two main drugs of the study (milrinone and dobutamine), and because of professional and ethical reasons there was no need to use adjuvant and Additional drugs in most cases, so the title of the study is summarized as follows.
Acronym
IRCT registration information
IRCT registration number:IRCT20211102052941N1
Registration date:2022-01-23, 1400/11/03
Registration timing:registered_while_recruiting
Last update:2022-07-15, 1401/04/24
Update count:1
Registration date
2022-01-23, 1400/11/03
Registrant information
Name
Mohammad Mortazavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 2389
Email address
mormo1375@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-12, 1400/10/22
Expected recruitment end date
2022-02-11, 1400/11/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of milrinone and dobutamine on pulmonary hypertension after adult heart valve replacement surgery
Public title
Comparison of the effect of milrinone and dobutamine on pulmonary hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidate for heart valve transplantation and suffering pulmonary hypertension (right ventricular systolic pressure ≥50mmHg or meanPAP ≥40 mmHg or systolic PAP is mor than 50% of systemic systolic pressure)
The age over 18 years old
The consent of patient to being involved
Exclusion criteria:
Renal and hepatic failure
Emergent surgery
Necessity to inotropic drugs before surgery
Long QT interval patients
Drug allergy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a randomized controlled clinical trial .before sampling, the order of assigning individuals to groups is determined randomly with random allocation software.In this way, before starting the sampling, patients are divided into two groups based on the Sequential turn number and as soon as they enter the study, they are assigned to one of the groups based on their turn number. In fact, patients are coded based on their turn number in the study and each code is randomly assigned to one of the groups. Individuals are assigned to groups by an operating room technologist outside the research team. The groups are marked with codes A and B and the researcher does not know the allocation of codes. Patients and the analyzer are also unaware of the medication received and the Drugs are blinded with names A and B. The group codes are opened after the analysis.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients, clinical caregivers, outcome assessors, and data analyst are unaware of the medication regimen used in each patient group. In this way, the patients and drug regimens are divided into two groups A and B before entering the study and each patient receives the desired medication regimen according to that, which are blinded with the names A and B. The group codes are opened after the analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar jerib Avenue, Isfahan, Isfahan Province
City
Isfahan
Province
Isfehan
Postal code
8168913866
Approval date
2021-01-25, 1399/11/06
Ethics committee reference number
IR.MUI.MED.REC.1399.980
Health conditions studied
1
Description of health condition studied
Pulmonary hypertension
ICD-10 code
I27.2
ICD-10 code description
Other secondary pulmonary hypertension
Primary outcomes
1
Description
Pulmonary blood pressure in millimeters of mercury
Timepoint
After induction of anesthesia, before CPB, after CPB, the ICU arrival moment and every 6 hours till 24 hours in ICU
Method of measurement
Pulmonary artery catheter
2
Description
Ejection fraction
Timepoint
Before surgery and 3 days after surgery
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:The group that receiving Intravenous infusion of milrinone at a dose of 0.5 - 0.75 μg / kg / min. Medication regimens commence from the time of patient`s rewarming and continue until the patient's condition stabilizes in the Intensive Care Unit under the anesthesia attending`s care .Milrinone is a phosphodiesterase III inhibitor commonly used after cardiopulmonary bypass in combination with adrenaline or noradrenaline μg/kg/min 0.1 - 0.5 to reduce pulmonary artery pressure with a synergistic inotropic effect. Noradrenaline made by BCWORLD PHARM CO. South Korea and Milrinon made by Baxter India.
Category
Treatment - Drugs
2
Description
Intervention group 2: The groupe that receiving Intravenous infusion of dobutamine 5-10 μg / kg / min. Dubotamine through strong agonist stimulation effect on Bradykinin 1 Receptor and moderate stimulation effect on Bradykinin 2 Receptor increases myocardial contractility and increases stroke volume, cardiac output and heart rate and decreases vascular resistance. After cardiac surgery, the combined use of dobutamine with Noradrenaline μg/kg/min 0.1 - 0.5 has more inotropic effect due to its competitive effect on Bradykinin 1 Receptor.Noradrenaline made by BCWORLD PHARM CO. South Korea and Dobutamine made by Darou Paksh- Iran.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Heart Educational, Medical and Research Center
Full name of responsible person
Mohammadreza Shafiei
Street address
2nd Moshtagh St ,Isfahan , Isfahan Province
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
Dean@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mansour Siavash Dasjerdi
Street address
Hezar Jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojtaba Mansouri
Position
Associate Professor of Cardiac Anesthesia
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Chamran Hospital , Second Moshtagh Avenue , Isfahan
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
Mansouri@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojtaba Mansouri
Position
Associate Professor of Cardiac Anesthesia
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Chamran Hospital , Second Moshtagh Avenue , Isfahan
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
Mansouri@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojtaba Mansouri
Position
Associate Professor of Cardiac Anesthesia
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Chamran Hospital , Second Moshtagh Avenue , Isfahan
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
Mansouri@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data from this study can be shared after Anonymizing individuals.
When the data will become available and for how long
Access starts after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data of the present study can be used in any situation and anywhere
From where data/document is obtainable
Mojtaba Mansouri
Mansouri@med.mui.ac.ir
What processes are involved for a request to access data/document
The documents and the file that can be published will be emailed immediately after verification, upon request of the applicant.