Comparison of the effect of nebulized milrinone and intravenous milrinone in patients with pulmonary hypertension who are candidates for open heart surgery
Design
After confirmationof pulmonary artery hypertention disorder,the admitted patients will be randomly assigned to open cruciate ligament in two groups:A(Intratracheal milrinone) and B (Intravenous infusion of milrinone).The study is a clinical trial with a samplesize of 16 people in parallel groups.
Settings and conduct
Patients referred to Ahvaz Golestan Hospital with a history of pulmonary artery hypertension undergoing open heart surgery are included in the study. Measurement of patient echocardiographic and hemodynamic factors such as: systolic blood pressure, diastolic blood pressure, mean arterial pressure (MAP), heart rate (HR) , Systolic, diastolic, mean pulmonary artery pressure (MPAP), central venous pressure, systemic vascular resistance (SVR) and PVR, cardiac output, pulmonary indices and (SVR PVRI, SVRI) before and after surgery again in trimester 10 , 30 and 60 minutes after surgery will also be measured.
Participants/Inclusion and exclusion criteria
patients with pulmonary hypertention enter the study field.
If the patient refuses,the presence of COPD and pulmonary hemorrhage are excluded.
Intervention groups
1.Milrinone infusion group 0.5mcg/kg/min at the end of CPB pum
2.Group of administration of 5 cc milrinon intratracheal at teh end of CPB pump
Main outcome variables
Pulmonary hypertension
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201104049266N1
Registration date:2020-12-06, 1399/09/16
Registration timing:registered_while_recruiting
Last update:2020-12-06, 1399/09/16
Update count:0
Registration date
2020-12-06, 1399/09/16
Registrant information
Name
sara Joreirahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3017
Email address
sjaca4913@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of nebulized milrinone and intravenous milrinone in patients with pulmonary hypertension who candidate of open-heart surgery
Public title
effect of nebulized milrinone and intravenous milrinone in patients with pulmonary hypertention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
candidated for open heart surgery
pulmonary pressure more than 40 mmhg
20 years <age <70 years
Exclusion criteria:
Patient refusal
redo surgery
COPD
Kindey or Hepatic Failure
LVEF<40mmhg
Pulmonary bleeding in pulmonary HTN
Mean pulmonary artery pressure>25mmhg
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed in a simple and individual manner with emphasis on the patient's case code and using a table of random numbers. In this method, all patients were coded and the code of each disease was randomly assigned to a group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahwaz Jundishapur University of Medical SCIENCES
Street address
cardaic surgery or, Golestan Hospital, Golestan Blvd
City
Ahwaz
Province
Khouzestan
Postal code
6135733118
Approval date
2020-11-02, 1399/08/12
Ethics committee reference number
iR.AJUMS.REC.1399.654
Health conditions studied
1
Description of health condition studied
Pulmonary HTN
ICD-10 code
I27.2
ICD-10 code description
Other secondary pulmonary hypertension
Primary outcomes
1
Description
Mean pulmonary artery pressure
Timepoint
During surgery
Method of measurement
Using a radial artery catheter and a pulmonary artery catheter and through the left internal jugular vein
2
Description
Pulmonary capillary wedge pressure
Timepoint
During surgery
Method of measurement
Using a radial artery catheter and a pulmonary artery catheter and through the left internal jugular vein
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Nebulized milrinone- In patients in this group, 2 mg of milrinone (dissolved in dextrose) is diluted in 3 ml of 9% sodium chloride and inhalation is complete within 15 minutes.
Category
Treatment - Drugs
2
Description
Control group: For patients in this group, 0.25-0.75 µg/kg/min milrinone will be injected intravenously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital , Ahvaz Jondishapur University of Medical Sciences
Full name of responsible person
Sara Joreirahmadi
Street address
Khuzestan - Ahvaz - Golestan - Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3030
Email
sjaca4913@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahdi Ahmadimoghaddam
Street address
Khuzestan - Ahvaz - Golestan - Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3373 8383
Email
ahmadi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Sara Joreirahmadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Khuzestan - Ahvaz - Golestan - Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3030
Email
sjaca4913@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sara Joreirahmadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Khuzestan - Ahvaz - Golestan - Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3030
Email
sjaca4913@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sara Joreirahmadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Khuzestan - Ahvaz - Golestan - Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3774 3030
Email
sjaca4913@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available