UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054149 |
|---|---|
| Receipt number | R000061835 |
| Scientific Title | Milrinone versus dobutamine as supportive agent for right ventricular dysfunction after cardiopulmonary bypass: a prospective randomized comparative study |
| Date of disclosure of the study information | 2024/04/16 |
| Last modified on | 2026/05/04 19:47:20 |
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Basic information
Public title
Milrinone versus dobutamine as supportive agent for right ventricular dysfunction after cardiopulmonary bypass: a prospective randomized comparative study
Acronym
Milrinone versus dobutamine as supportive agent for right ventricular dysfunction after cardiopulmonary bypass
Scientific Title
Milrinone versus dobutamine as supportive agent for right ventricular dysfunction after cardiopulmonary bypass: a prospective randomized comparative study
Scientific Title:Acronym
Milrinone versus dobutamine as supportive agent for right ventricular dysfunction after cardiopulmonary bypass
Region
| Africa |
Condition
Condition
active
Classification by specialty
| Cardiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to compare milrinone and dobutamine regarding their efficacy and safety in managing RV dysfunction after cardiopulmonary bypass during cardiac surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Echocardiographic RV function indices TAPSE
Key secondary outcomes
Other echocardiographic parameters RVFAC, PASP, LVOT VTI
Duration of mechanical ventilation
Length of ICU stay
Incidence of significant arrhythmias (new onset AF, VT) requiring intervention
Incidence of profound hypotension (MAP <55 mmHg) requiring rescue therapy
Need for additional inotropic or vasopressor support
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Milrinone group (M group) will include patients who will be subjected to milrinone a loading dose of milrinone acetate 50 mic/kg over 10 minutes followed by 0.3-0.8 mic/kg/min. infusion.
Interventions/Control_2
Dobutamine group (D group) will include patients who will be subjected to 2-10 mic/kg/min intravenous infusion.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients over 18 years scheduled for on pump cardiac surgery who developed new RV systolic dysfunction after CPB separation were eligible. RV dysfunction was defined as TAPSE less than 17 mm on intraoperative echocardiography together with clinical signs requiring inotropic support persistent hypotension and elevated CVP. Enrolment occurred when the clinical team decided to initiate inotropic therapy during or immediately after CPB weaning
Key exclusion criteria
Emergency surgery
Prior intake of inotropic support.
Severe hepatic, renal impairment.
Patients for pulmonary thromboendarterectomy,
Contraindication for use of TEE
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Mohammed |
| Middle name | Adel |
| Last name | Hegazy |
Organization
Mansoura university
Division name
anesthesia and surgical intensive care department
Zip code
35511
Address
Anesthesia and ICU faculty of Medicine Mansoura University
TEL
0020502205178
dr_mhegazy7000@mans.edu.eg
Public contact
Name of contact person
| 1st name | mohammed |
| Middle name | adel |
| Last name | hegazy |
Organization
Mansoura university hospital
Division name
anesthesia and surgical intensive care department
Zip code
35511
Address
Anesthesia and ICU faculty of Medicine Mansoura University
TEL
0020502205178
Homepage URL
dr_mhegazy7000@mans.edu.eg
Sponsor or person
Institute
Mansoura university hospitals
Institute
Department
Personal name
Funding Source
Organization
Mansoura university hospitals
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Research Board - IRB Faculty of Medicine - Mansoura University
Address
institutional review board office - building A ground floor faculty of medicine Mansoura university
Tel
00201092127930
IRB,MFM@hotmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061835
