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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00862407
Recruitment Status : Recruiting
First Posted : March 16, 2009
Last Update Posted : February 25, 2020
Sponsor:
Collaborator:
Penn State University
Information provided by (Responsible Party):
Akif Undar, Milton S. Hershey Medical Center

Brief 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.


Condition or disease
Cardio-Pulmonary Bypass

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Pulsatile CPB on Vital Organ Recovery
Study Start Date : October 2008
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs

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



Primary Outcome Measures :
  1. Changes in plasma proteins [ Time Frame: 24 hours ]

Biospecimen Retention:   Samples Without DNA
Blood and plasma samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
300 children (150 per perfusion system) ages 1 year to < 18 years requiring CPB for cardiac surgery.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862407


Contacts
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Contact: Akif Undar, PhD 717-531-6706 aundar@psu.edu

Locations
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United States, Pennsylvania
Penn State College of Medicine Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Akif Undar, PhD    717-531-6706    aundar@psu.edu   
Principal Investigator: Akif Undar, PhD         
Sub-Investigator: John L Myers, MD         
Sub-Investigator: Joseph B Clark, MD         
Sub-Investigator: Neal Thomas, MD         
Sub-Investigator: Linda Pauliks, MD         
Sub-Investigator: Jennifer L Stokes, RN         
Sponsors and Collaborators
Milton S. Hershey Medical Center
Penn State University
Additional Information:
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Responsible Party: Akif Undar, Professor of Pediatrics, Surgery, & Bioengineering, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00862407    
Other Study ID Numbers: 19299
First Posted: March 16, 2009    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Keywords provided by Akif Undar, Milton S. Hershey Medical Center:
Cardiopulmonary bypass
Non-pulsatile perfusion
Pulsatile perfusion
plasma proteins