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NCT Number: NCT00862407

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardio-pulmonary Bypass

Age range

1 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Changes in plasma proteins

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Penn State University

Registry information

Official study title

Impact of Pulsatile CPB on Vital Organ Recovery

Important dates

Study start
2008
Primary completion
2028
Study completion
2030
First posted
Mar 16, 2009
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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