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

NCT04260204 | Completed DMC

• 1 other identifier: ACTS004367
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Congenital Heart Disease

Keywords

retrograde autologous priming pulmonary mechanics

Outcome Measures

Primary Outcomes (5)

• Comparison of postoperative peak air way pressure between the studied groups

  peak air way pressure (Paw) in cmH2O

  1 hour after surgery

• Comparison of postoperative air way resistance between the studied groups

  air way resistance (Raw) in cmH2O/L/sec.

  1 hour after surgery

• Comparison of postoperative Plateau pressure between the studied groups

  Plateau pressure in cm H2O

  1 hour after surgery

• Comparison of postoperative Lung compliance between the studied groups

  Lung compliance in L/cm H2O

  1 hour after surgery

• Comparison of postoperative Tidal volume between the studied groups

  Tidal volume in ml

  1 hour after surgery

Study Arms (2)

Retrograde priming

ACTIVE COMPARATOR

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

conventional priming

ACTIVE COMPARATOR

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

Interventions

Pediatric cardiac surgery PROCEDURE

Retrograde priming; conventional priming

Eligibility Criteria

• Age: 12 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• cyanotic heart disease

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hamdy Singab, PhD

  Ain shams university faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: February 1, 2020
• First Posted: February 7, 2020
• Study Start: January 2, 2015
• Primary Completion: December 30, 2019
• Study Completion: January 25, 2020
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months
• Access Criteria: Pediatric cardiac surgeon