Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury
2 other identifiers
interventional
1,100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2024
CompletedFirst Posted
Study publicly available on registry
April 5, 2024
CompletedStudy Start
First participant enrolled
May 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
May 21, 2025
May 1, 2025
2.9 years
March 19, 2024
May 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Acute kidney injury
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
From intensive care unit admission after surgery up to 7 days
Secondary Outcomes (5)
Acute kidney injury risk score
On admission to the intensive care unit after surgery up to 24 hours after intensive care unit arrival
Red blood cell units transfused
After cardiopulmonary bypass up to 24 hours after intensive care unit arrival
Platelet nadir
On admission to the intensive care unit after surgery up to 7 days
Discontinuation rate of cardiopulmonary bypass mode
During cardiopulmonary bypass
30-day mortality
From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other Outcomes (21)
Myocardial infarction
From intensive care unit admission after surgery to hospital discharge, up to 30 days
Stroke
From intensive care unit admission after surgery to hospital discharge, up to 30 days
Renal failure requiring renal replacement therapy
From intensive care unit admission after surgery to hospital discharge, up to 30 days
- +18 more other outcomes
Study Arms (2)
Non-pulsatile blood flow
ACTIVE COMPARATORNon-pulsatile blood flow during cardiopulmonary bypass
Pulsatile blood flow
ACTIVE COMPARATORPulsatile blood flow during cardiopulmonary bypass
Interventions
Non-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass
Pulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass
Eligibility Criteria
You may qualify if:
- Able to provide informed consent
- Scheduled for elective cardiac surgery with cardiopulmonary bypass
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Related Publications (3)
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.
PMID: 35258532BACKGROUNDKhwaja 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.
PMID: 22890468BACKGROUNDTan 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.
PMID: 36380831BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan J Clendenen, MD, MS
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2024
First Posted
April 5, 2024
Study Start
May 19, 2025
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
October 1, 2028
Last Updated
May 21, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share