Effect of Nebulized Milrinone on Right Ventricular Hemody... | NCT05132153

Studies
Effect of Nebulized Milrinone on Right Ventricular Hemodynamics in Adult Cardiac Surgery

NCT05132153

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Jul 20, 2022Actual

Enrollment

70Estimated

Phase

Phase 4

Conditions

Anesthesia

Interventions

Milrinone
Normal saline

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2021Actual

Primary Completion Date

Sep 1, 2022Estimated

Completion Date

Sep 20, 2022Estimated

First Submitted Date

Oct 22, 2021

First Submission Date that Met QC Criteria

Nov 19, 2021

First Posted Date

Nov 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2022

Last Update Posted Date

Jul 20, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary aim of this study was to investigate the effect inhaled milrinone given before CPB on improving the right ventricular function measured by transesophageal echocardiography (TEE) at time of CPB separation.

Detailed Description

The investigator will include (70) patients planned for elective adult cardiac surgery (Coronary revascularization surgery, Mitral valve surgery, Aortic valve surgery or complex surgery (either two or more valves or valves and coronary revascularization surgery). All surgery should be with CPB. All patients will be diagnosed with preoperative PH. After separation of CPB the patients evaluated as regard the hemodynamics (MAP, HR), the inotropic score as additional intravenous milrinone in the case of low cardiac output or presence of post-CPB PH or RV failure with reduced contractility documented using TEE. Left ventricular EF, and right ventricular hemodynamics represented by RV function measured by (tricuspid annulus plane systolic excursion (TAPSE), fractional area change FAC), and right ventricular systolic pressure by doppler (RVSP) which represent the pulmonary artery pressure all data will be assessed by transesophageal ECHO after anesthesia, immediately before CPB and immediately after separation from CPB all these data will be recorded in the study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
(Group A) will receive milrinone	Active Comparator	Patients will receive milrinone 50 microgram/kg in 5ml volume, over 5 min by nebulization	Drug: Milrinone
(Group B) will receive normal saline	Placebo Comparator	Patients will receive 5 ml saline by nebulization over 5 min	Drug: Normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Milrinone	Drug	will be given by nebulization	(Group A) will receive milrinone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of inhaled milrinone on improvement of right ventricular function	The right ventricle function will be assessed by Fractional area change ( Change in area between systole and diastole by echocardiograph ( intraoperative and postoperative)	After 15 minutes of inhaled milrinone intraoperative and repeated after 12, 24 hours in intensive care unit

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Eligibility criteria:

elective adult cardiac surgery (Coronary revascularization surgery, Mitral valve surgery, Aortic valve surgery or complex surgery (either two or more valves or valves and coronary revascularization surgery).
All surgery should be with CPB.
All patients will be diagnosed with preoperative PH. PH was defined as a mean pulmonary artery pressure (MPAP) 30 mmHg or a systolic pulmonary artery pressure (SPAP) 40 mmHg, measured during preoperative right-sided catheterization or estimated by using doppler transthoracic echocardiography.

Exclusion Criteria:

Cardiac surgery without CPB.
Hemodynamic instability in the preoperative time (defined as acute requirement for vasoactive support or mechanical device).
Adult congenital heart disease planned for corrective surgery.
Contraindication to transesophageal echocardiography (TEE).
Any surgery involves tricuspid valve annulus as it will compromise the accuracy of RV function assessment by TEE.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Samar Soliman	Contact	01006236494		dr_sm.md@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samar Soliman	Recruiting	Cairo	Nasr City	11511	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D020105	Milrinone
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000676	Amrinone
D000631	Aminopyridines
D000588	Amines
D009930	Organic Chemicals
D011725

Browse Leaves

Not provided

Browse Branches

Not provided