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

NCT ID: NCT00862407

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardio-Pulmonary Bypass

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

Non-pulsatile Group (conventional)

No interventions assigned to this group

2

Pulsatile group (Alternate)

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Penn State University

OTHER

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Akif Undar

Professor of Pediatrics, Surgery, & Bioengineering

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Penn State College of Medicine

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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http://www.hmc.psu.edu/childrens/pedscpb/

International Conference on pediatric heart pumps

Other Identifiers

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19299

Identifier Type: -

Identifier Source: org_study_id

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