RAPCPB: Effect of Retrograde Autologous Blood Priming on Pulmonary Mechanics in Pediatric Cardiac Surgery

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT04260204

Collaborator

(none)

124

Enrollment

Arms

60.7

Actual Duration (Months)

Study Details

Study Description

Brief Summary

The present study hypothesized that beyond its hemodynamic affects,retrograde autologus blood priming of cardiopulmonary bypass (RAP) has a positive impact on hemodynamics and pulmonary mechanics subjected to cardiac surgery.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease	Procedure: Pediatric cardiac surgery	N/A

Detailed Description

This prospective randomized study analyzed the clinical records of 124 children subjected to cardiac surgery for congenital heart diseases with left to right shunt. They comprised 64 patients with RAP and 60 patients conventional cardiopulmonary bypass priming. The preoperative, intraoperative and postoperative data of the studied patients were reported.

Study Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients were included in the study if they had left to right shunt due to volume or pressure overloadPatients were included in the study if they had left to right shunt due to volume or pressure overload

Masking:

Double (Participant, Investigator)

Masking Description:

double-blind masking

Primary Purpose:

Prevention

Official Title:

Effect of Retrograde Autologous Blood Priming of Cardiopulmonary Bypass on Hemodynamic Parameters and Pulmonary Mechanics in Pediatric Cardiac Surgery

Actual Study Start Date :

Jan 2, 2015

Actual Primary Completion Date :

Dec 30, 2019

Actual Study Completion Date :

Jan 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Retrograde priming retrograde autologous Blood Priming of Cardiopulmonary Bypass (RAP) in young children subjected to cardiac surgery for congenital heart defects with left to right shunt associated with volume or pressure overload.	Procedure: Pediatric cardiac surgery
Active Comparator: conventional priming conventional cardiopulmonary priming in young children subjected to cardiac surgery for congenital heart defects with left to right shunt associated with volume or pressure overload.	Procedure: Pediatric cardiac surgery

Arm

Intervention/Treatment

Active Comparator: Retrograde priming

retrograde autologous Blood Priming of Cardiopulmonary Bypass (RAP) in young children subjected to cardiac surgery for congenital heart defects with left to right shunt associated with volume or pressure overload.

Procedure: Pediatric cardiac surgery

Active Comparator: conventional priming

conventional cardiopulmonary priming in young children subjected to cardiac surgery for congenital heart defects with left to right shunt associated with volume or pressure overload.

Procedure: Pediatric cardiac surgery

Outcome Measures

Primary Outcome Measures

Comparison of postoperative peak air way pressure between the studied groups [1 hour after surgery]
peak air way pressure (Paw) in cmH2O
Comparison of postoperative air way resistance between the studied groups [1 hour after surgery]
air way resistance (Raw) in cmH2O/L/sec.
Comparison of postoperative Plateau pressure between the studied groups [1 hour after surgery]
Plateau pressure in cm H2O
Comparison of postoperative Lung compliance between the studied groups [1 hour after surgery]
Lung compliance in L/cm H2O
Comparison of postoperative Tidal volume between the studied groups [1 hour after surgery]
Tidal volume in ml

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

children complained of congenital heart disease with left to right shunt pressure or volume load

Exclusion Criteria:

cyanotic heart disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Hamdy Singab, PhD, Ain shams university faculty of medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Hamdy Singab, Professor, Ain Shams University

ClinicalTrials.gov Identifier:

NCT04260204

Other Study ID Numbers:

ACTS004367

First Posted:

Feb 7, 2020

Last Update Posted:

Mar 4, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. Hamdy Singab, Professor, Ain Shams University

retrograde autologous priming pulmonary mechanics

Additional relevant MeSH terms:

Heart Diseases

Heart Defects, Congenital

Study Results

No Results Posted as of Mar 4, 2020