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NCT00862407 Clinical Trial

Impact of Pulsatile Cardio-Pulmonary Bypass (CPB) on Vital Organ Recovery

Cardio-Pulmonary Bypass Clinical Trial

Official title:
Impact of Pulsatile CPB on Vital Organ Recovery

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00862407
Other study ID # 19299
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 2008
Est. completion date December 31, 2028

Study information
Verified date July 2022
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This research study is about the effect heart-lung bypass procedures have on the vital organs (brain, heart, lungs, and kidneys) during open-heart surgery in pediatric patients. There are two types of heart pumps used in surgery requiring heart-lung bypass; one pumps the blood continuously through the body and the other pumps the blood with repeated pulses. Both pumps are approved for clinical use by the FDA. Although 90% of institutions still use non-pulsatile flow, some studies show there may be benefits to using pulsatile flow during surgery. The investigators want to learn whether the vital organs (brain, heart, lungs, and kidneys) respond differently to one method than they do to the other. Approximately 300 children will take part in this research at the Hershey Medical Center.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date December 31, 2028
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 1 Day to 17 Years
Eligibility Inclusion Criteria: - Patients recruited from Penn State Children's Hospital undergoing cardiac surgery with cardiopulmonary bypass. Exclusion Criteria: - Patients older than 17 years will be excluded.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Penn State College of Medicine Hershey Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Milton S. Hershey Medical Center Penn State University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in plasma proteins 24 hours
See also
  Status Clinical Trial Phase
Recruiting NCT05875272 - Interchangeability of Arterial Coagulation and Venous Coagulation, in the Context of Cardiac Surgeries Under Cardiopulmonary Bypass, Using the DMDiv Hemochron Signature Elite
Not yet recruiting NCT05079724 - Acute Kidney Injury After Cardiac Surgery
Completed NCT00048308 - Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardio-Pulmonary Bypass Phase 3

External Links