Protocol summary
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Study aim
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Determining and comparing the effect of Milrinone and dobutamine on adult`s pulmonary hypertension after heart valve replacement surgery
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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Reduction of pulmonary hypertension, reduction of mechanical respiration, reduction of inotropic drug using duration, reduction of ICU hospitalization, reduction of tachycardia
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2022-01-23, 1400/11/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-01-12, 1400/10/22
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Expected recruitment end date
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2022-02-11, 1400/11/22
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparative study of the effect of milrinone and dobutamine on pulmonary hypertension after adult heart valve replacement surgery
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Public title
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Comparison of the effect of milrinone and dobutamine on pulmonary hypertension
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
38
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-01-25, 1399/11/06
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Ethics committee reference number
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IR.MUI.MED.REC.1399.980
Health conditions studied
1
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Description of health condition studied
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Pulmonary hypertension
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ICD-10 code
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I27.2
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ICD-10 code description
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Other secondary pulmonary hypertension
Primary outcomes
1
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Description
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Pulmonary blood pressure in millimeters of mercury
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Timepoint
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After induction of anesthesia, before CPB, after CPB, the ICU arrival moment and every 6 hours till 24 hours in ICU
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Method of measurement
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Pulmonary artery catheter
2
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Description
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Ejection fraction
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Timepoint
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Before surgery and 3 days after surgery
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Method of measurement
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Echocardiography
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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All data from this study can be shared after Anonymizing individuals.
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When the data will become available and for how long
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Access starts after the results are published
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To whom data/document is available
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The data will be available only to researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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The data of the present study can be used in any situation and anywhere
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From where data/document is obtainable
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Mojtaba Mansouri
Mansouri@med.mui.ac.ir
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What processes are involved for a request to access data/document
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The documents and the file that can be published will be emailed immediately after verification, upon request of the applicant.
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Comments
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