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

Penn State Health

Status: Active, not recruiting

Conditions: Cardio-Pulmonary Bypass

Study type: Observational

Funder types: Other

Identifiers

NCT00862407

19299

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 1 day to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

1

Description:

Non-pulsatile Group (conventional)

2

Description:

Pulsatile group (Alternate)