Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06349577

Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Kidney Injury Blood Platelet Disorders Cytopenia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hemolysis Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Surgery Thrombocytopenia Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Nathan Clendenen, MD MS

CONTACT

[email protected]

Nathan J Clendenen, MD MS

PRINCIPAL_INVESTIGATOR

About this study

Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass for cardiac surgery are both considered standard of care and allow surgeons to operate on the heart without movement. Pulsatile cardiopulmonary bypass produces variations in blood flow to produce a pulse similar to a normal beating heart. Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass are approved as safe and effective ways to provide perfusion during cardiac surgery, but it is unknown whether there are differences in clinical outcomes after surgery. Acute kidney injury is common after cardiac surgery and may be caused by inadequate perfusion during cardiopulmonary bypass.

Specific Aim: The purpose of this study is to determine the effectiveness of pulsatile blood flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.

Hypothesis: Pulsatile blood flow during cardiopulmonary bypass will reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Acute kidney injury

    Time frame: From intensive care unit admission after surgery up to 7 days

    Stage 1 (mild), 2 (moderate), or 3 (severe) acute kidney injury according to the Kidney Disease Improving Global Outcomes creatinine criteria (stage 1 = 1.5 to 1.9 times baseline or greater than or equal to 0.3 milligrams per deciliter increase in serum creatinine, stage 2 = 2.0 to 2.9 times baseline in serum creatinine, stage 3 = 3.0 times baseline or increase in serum creatinine greater than or equal to 4.0 milligrams per deciliter or initiation of renal replacement therapy

Secondary outcomes

  1. Acute kidney injury risk score

    Time frame: On admission to the intensive care unit after surgery up to 24 hours after intensive care unit arrival

    Demirjian Perioperative Laboratory Test-Based Prediction Model for Moderate to Severe Acute Kidney Injury After Cardiac Surgery in percent predicted risk

  2. Red blood cell units transfused

    Time frame: After cardiopulmonary bypass up to 24 hours after intensive care unit arrival

    Number of allogenic red blood cell units transfused after cardiopulmonary bypass

  3. Platelet nadir

    Time frame: On admission to the intensive care unit after surgery up to 7 days

    Lowest platelet count after cardiopulmonary bypass

  4. Discontinuation rate of cardiopulmonary bypass mode

    Time frame: During cardiopulmonary bypass

    Discontinuation rate of pulsatile or non-pulsatile cardiopulmonary bypass mode

  5. 30-day mortality

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    All cause mortality

Other outcomes

  1. Myocardial infarction

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Myocardial infarction by clinical diagnosis

  2. Stroke

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Stroke by clinical diagnosis

  3. Renal failure requiring renal replacement therapy

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    New diagnosis of renal failure requiring renal replacement therapy

  4. Re-exploration for bleeding

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Surgical re-exploration for bleeding

  5. Sepsis

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Diagnosed by positive blood culture

  6. New onset atrial fibrillation

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Clinical diagnosis of new onset atrial fibrillation

  7. Duration of mechanical ventilation

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Duration of mechanical ventilation

  8. Post-operative delirium

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Post-operative determined by the Confusion Assessment Method for the Intensive Care Unit

  9. Post-operative hospital length of stay

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Post-operative hospital length of stay

  10. New requirement for mechanical circulatory support

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    New requirement for mechanical circulatory support

  11. Intra-operative red blood cell transfusion in units

    Time frame: During the intra-operative time period, up to 12 hours

    Intra-operative red blood cell transfusion in units

  12. Post-operative red blood cell transfusion in units

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Post-operative red blood cell transfusion in units

  13. Post-operative platelet transfusion in units

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Post-operative platelet transfusion in units

  14. Post-operative plasma transfusion in units

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Post-operative plasma transfusion in units

  15. Post-operative cryoprecipitate transfusion in units

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Post-operative cryoprecipitate transfusion in units

  16. Intra-operative platelet transfusion in units

    Time frame: During the intra-operative time period, up to 12 hours

    Intra-operative platelet transfusion in units

  17. Intra-operative plasma transfusion in units

    Time frame: During the intra-operative time period, up to 12 hours

    Intra-operative plasma transfusion in units

  18. Intra-operative cryoprecipitate transfusion in units

    Time frame: During the intra-operative time period, up to 12 hours

    Intra-operative cryoprecipitate transfusion in units

  19. New onset of acute lung injury

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Diagnosis of acute lung injury by PaO2 to FiO2 ratio ≤ 300

  20. New onset of left ventricular systolic dysfunction

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    New onset of left ventricular systolic dysfunction determined by a LV ejection fraction <50%

  21. New onset of right ventricular systolic dysfunction

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    New onset of right ventricular systolic dysfunction determined by a tricuspid annular plane systolic excursion less than 16 mm

Study contacts

Contact information is provided by the study sponsor or research team.

Nathan J Clendenen, MD,MS

CONTACT

[email protected]

3037245000

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 5, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.