NCT00862407

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

Impact of Pulsatile CPB on Vital Organ Recovery

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 1 Day – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardio-Pulmonary Bypass

Timeline

• Start date: 2008-10-01
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2009-03-16
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States