Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06349577
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Non-pulsatile blood flow — OTHER
    Non-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass
  • Pulsatile blood flow — OTHER
    Pulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass

Study Details

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.

Key Dates

Start date
May 19, 2025
Status verified
May 2025
Primary completion
Apr 30, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
1,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Non-pulsatile blood flow
    Non-pulsatile blood flow during cardiopulmonary bypass
  • Active Comparator: Pulsatile blood flow
    Pulsatile blood flow during cardiopulmonary bypass

Primary Outcome Measure

Acute kidney injury [ Time Frame: From intensive care unit admission after surgery up to 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045
Nathan Clendenen, MD MS
[email protected]
Nathan J Clendenen, MD MS (PRINCIPAL_INVESTIGATOR)

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By research site
University of Colorado Hospital· Aurora, CO

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