Recruiting

Cardiopulmonary Bypass

Sponsor:

University of Colorado, Denver

Code:

NCT05344573

Conditions

Endothelial Dysfunction

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Cardiopulmonary bypass during cardiac surgery provides blood flow to the body during surgery but has adverse effects on different organs. Blood flow during cardiopulmonary bypass may be pulsatile or non-pulsatile, which may impact normal organ function after surgery. The study will collect data on the type of cardiopulmonary bypass used during surgery and organ function to determine if there is an association between the type of bypass and organ function.

Conditions

Endothelial Dysfunction

Acute Kidney Injury

Study ID

NCT05344573

Start date

Jul 5, 2022

Status verified date

Nov, 2024

Completion date

Jul 1, 2025

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 50 to 70
  • Able to provide informed consent
  • Scheduled for elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

  • Patients undergoing emergency procedures
  • Diagnosed with sepsis
  • Experiencing delirium
  • Experiencing hemodynamic instability (heart rate > 100 and systolic blood pressure < 90)
  • Patients with a mechanical circulatory support device
  • Requiring vasoactive medications before surgery
  • Patients with a reduced left ventricular ejection fraction (less than 50%)
  • Patients with a contraindication to transesophageal echocardiography

Study Design

Enrollment

66 participants

Anticipated

Interventions and Outcome Measures

Arms

Non-pulsatile cardiopulmonary bypass

Subjects who undergo cardiac surgery with non-pulsatile cardiopulmonary bypass

Pulsatile cardiopulmonary bypass

Subjects who undergo cardiac surgery with pulsatile cardiopulmonary bypass

Primary outcome measure

  • Endothelial function [ Time Frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days ]

Central Contacts and Locations

Central contacts

Nathan J Clendenen, MD, MS

(303) 724-5375nathan.clendenen@cuanschutz.edu

Locations

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Nathan Clendenen, MD MS

303-724-5000nathan.clendenen@cuanschutz.edu

Principal Investigator:

Nathan J Clendenen, MD MS

More Information

Sponsor

University of Colorado, Denver

Last update posted

Nov 21, 2024

Last verified

Nov, 2024

Keywords

  • Endothelial function
  • Acute Kidney Injury
  • Cardiopulmonary bypass
  • Cardiac surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-11-21.