Recruiting

Pulsatile Flow vs. Non-Pulsatile Flow

Sponsor:

University of Colorado, Denver

Code:

NCT06349577

Conditions

Acute Kidney Injury

Hemolysis

Thrombocytopenia

Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Non-pulsatile blood flow

Pulsatile blood flow

Study Details

Brief summary:

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.

Conditions

Acute Kidney Injury

Hemolysis

Thrombocytopenia

Surgery

Study ID

NCT06349577

Start date

May 19, 2025

Status verified date

May, 2025

Completion date

Oct, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria

  • Emergency procedures
  • Scheduled for heart or lung transplantation
  • Scheduled for ventricular assist device implantation
  • Use of the Medtronic Elongated Once-Piece Arterial Cannula
  • Diagnosed with sepsis
  • Diagnosed with delirium
  • Experiencing hemodynamic instability (heart rate > 100 and systolic blood pressure < 90)
  • Requiring mechanical circulatory support
  • Requiring vasoactive medications

Study Design

Enrollment

1100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

Non-pulsatile blood flow

Non-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass

Pulsatile blood flow

Pulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Nathan J Clendenen, MD,MS

3037245000nathan.clendenen@cuanschutz.edu

Locations

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Nathan Clendenen, MD MS

nathan.clendenen@cuanschutz.edu

Principal Investigator:

Nathan J Clendenen, MD MS

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 21, 2025

Last verified

May, 2025

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 2025-05-21.