Comparative evaluation between 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 two drug regimens noradrenaline plus Milrinone versus noradrenaliene plus dobutamine`s effect on adult`s pulmonary hypertension after heart valve implantation.
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 + 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.
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 noradrenaline with milrinone and the group that receiving noradrenaline with dobutamine
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
Acronym
IRCT registration information
IRCT registration number:IRCT20211102052941N1
Registration date:2022-01-23, 1400/11/03
Registration timing:registered_while_recruiting
Last update:2022-01-23, 1400/11/03
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 evaluation between two drug regimens Noradrenaline plus Milrinone versus Noradrenaliene plus Dobutamine`s effect on adult`s pulmonary hypertension after heart valve implantation.
Public title
Comparison of the effect of two drug regimens of noradrenaline plus milrinone and noradrenaline plus 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 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.
Category
Treatment - Drugs
2
Description
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.
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.