Clinical trial NCT06349577: Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury
Official title: Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Hemolysis
Thrombocytopenia
Surgery
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-04-05
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute kidney injury
timeFrame: From intensive care unit admission after surgery up to 7 days
Secondary outcomes:
measure: Acute kidney injury risk score
timeFrame: On admission to the intensive care unit after surgery up to 24 hours after intensive care unit arrival
measure: Red blood cell units transfused
timeFrame: After cardiopulmonary bypass up to 24 hours after intensive care unit arrival
measure: Platelet nadir
timeFrame: On admission to the intensive care unit after surgery up to 7 days
measure: Discontinuation rate of cardiopulmonary bypass mode
timeFrame: During cardiopulmonary bypass
measure: 30-day mortality
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other outcomes:
measure: Myocardial infarction
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Stroke
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Renal failure requiring renal replacement therapy
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Re-exploration for bleeding
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Sepsis
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: New onset atrial fibrillation
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Duration of mechanical ventilation
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Post-operative delirium
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Post-operative hospital length of stay
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: New requirement for mechanical circulatory support
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Intra-operative red blood cell transfusion in units
timeFrame: During the intra-operative time period, up to 12 hours
measure: Post-operative red blood cell transfusion in units
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Post-operative platelet transfusion in units
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Post-operative plasma transfusion in units
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Post-operative cryoprecipitate transfusion in units
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Intra-operative platelet transfusion in units
timeFrame: During the intra-operative time period, up to 12 hours
measure: Intra-operative plasma transfusion in units
timeFrame: During the intra-operative time period, up to 12 hours
measure: Intra-operative cryoprecipitate transfusion in units
timeFrame: During the intra-operative time period, up to 12 hours
measure: New onset of acute lung injury
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: New onset of left ventricular systolic dysfunction
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: New onset of right ventricular systolic dysfunction
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Nathan J Clendenen, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Demirjian S, Bashour CA, Shaw A, Schold JD, Simon J, Anthony D, Soltesz E, Gadegbeku CA. Predictive Accuracy of a Perioperative Laboratory Test-Based Prediction Model for Moderate to Severe Acute Kidney Injury After Cardiac Surgery. JAMA. 2022 Mar 8;327(10):956-964. doi: 10.1001/jama.2022.1751.
citation: Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
citation: Tan A, Newey C, Falter F. Pulsatile Perfusion during Cardiopulmonary Bypass: A Literature Review. J Extra Corpor Technol. 2022 Mar;54(1):50-60. doi: 10.1182/ject-50-60.