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IRCT20211102052941N1 IRCT 2022-01-23 Esfahan University of Medical Sciences Comparison of the effect of milrinone and dobutamine on pulmonary hypertension Comparative study of the effect of milrinone and dobutamine on pulmonary hypertension after adult heart valve replacement surgery 2022-01-12 anticipated 38 Complete https://irct.ir/trial/59758 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Pulmonary hypertension. Intervention 1: 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 2: 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. Yes - There is a plan to make this available What will be shared: All data from this study can be shared after Anonymizing individuals. When: Access starts after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: The data of the present study can be used in any situation and anywhere Where to obtain: Mojtaba Mansouri Mansouri@med.mui.ac.ir How to obtain: The documents and the file that can be published will be emailed immediately after verification, upon request of the applicant. Comments:
public Mojtaba Mansouri
Shahid Chamran Hospital , Second Moshtagh Avenue , Isfahan
Isfahan Iran (Islamic Republic of) 8166173414 +98 31 3260 0961 Mansouri@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mojtaba Mansouri
Shahid Chamran Hospital , Second Moshtagh Avenue , Isfahan
Isfahan Iran (Islamic Republic of) 8166173414 +98 31 3260 0961 ‫Mansouri@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both Renal and hepatic failure Emergent surgery Necessity to inotropic drugs before surgery Long QT interval patients Drug allergy I27.2 Other secondary pulmonary hypertension Treatment - Drugs Treatment - Drugs 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 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. 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. Ejection fraction. Timepoint: Before surgery and 3 days after surgery. Method of measurement: Echocardiography. Esfahan University of Medical Sciences Approved 2021-01-25 Ethics committee of Isfahan University of Medical Sciences Hezar jerib Avenue, Isfahan, Isfahan Province Isfahan Isfehan Iran (Islamic Republic of)