RECRUITING

Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective is to determine the effectiveness of pulsatile flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery. Investigators will also evaluate the safety and impact of pulsatile flow on clinical outcomes compared to non-pulsatile flow during cardiopulmonary bypass.

Official Title

Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Randomized Controlled Trial

Quick Facts

Study Start:2025-05-19
Study Completion:2028-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06349577

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.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to provide informed consent
  2. * Scheduled for elective cardiac surgery with cardiopulmonary bypass
  3. * Emergency procedures
  4. * Scheduled for heart or lung transplantation
  5. * Scheduled for ventricular assist device implantation
  6. * Use of the Medtronic Elongated Once-Piece Arterial Cannula
  7. * Diagnosed with sepsis
  8. * Diagnosed with delirium
  9. * Experiencing hemodynamic instability (heart rate \> 100 and systolic blood pressure \< 90)
  10. * Requiring mechanical circulatory support
  11. * Requiring vasoactive medications
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Nathan J Clendenen, MD,MS
CONTACT
3037245000
nathan.clendenen@cuanschutz.edu

Principal Investigator

Nathan J Clendenen, MD, MS
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

University of Colorado Hospital
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Nathan J Clendenen, MD, MS, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

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 Registration Dates

Study Start Date2025-05-19
Study Completion Date2028-10

Study Record Updates

Study Start Date2025-05-19
Study Completion Date2028-10

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Kidney Injury
  • Hemolysis
  • Thrombocytopenia
  • Surgery