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

April 7, 2026 updated by: Akif Undar, Milton S. Hershey Medical Center

Impact of Pulsatile 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.

Study Overview

Status

Active, not recruiting

Conditions

Cardio-Pulmonary Bypass

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Penn State College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 17 years (Child)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

300 children (150 per perfusion system) ages 1 year to < 18 years requiring CPB for cardiac surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 Non-pulsatile Group (conventional)
2 Pulsatile group (Alternate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in plasma proteins Time Frame: 24 hours	24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

Penn State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

March 13, 2009

First Submitted That Met QC Criteria