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

March 3, 2020 updated by: Dr. Hamdy Singab, Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • cyanotic heart disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Hamdy Singab, PhD, Ain Shams University Faculty Of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2015

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

January 25, 2020

Study Registration Dates

First Submitted

February 1, 2020

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 7, 2020

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTS004367

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Pulmonary mechanics improvement in pediatric patients undergoing cardiac surgery with retrograde autologous priming

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

Pediatric cardiac surgeon

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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