Predictive Accuracy of a Perioperative Laboratory Test-Based Prediction Model for Moderate to Severe Acute Kidney Injury After Cardiac Surgery.
Sevag Demirjian, C Allen Bashour, Andrew Shaw...
https://pubmed.ncbi.nlm.nih.gov/35258532Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID06349577
Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Randomized Controlled Trial
Led by University of Colorado, Denver · Updated on 2025-05-21
1100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of pulsatile blood flow during cardiopulmonary bypass to reduce the risk of acute kidney injury following cardiac surgery. Pulsatile flow mimics the natural pulse of a beating heart, compared to non-pulsatile flow which provides a constant blood flow. The study aims to compare these two methods to see if pulsatile flow improves clinical outcomes after surgery, particularly kidney health. Participants will be randomly assigned to receive either pulsatile or non-pulsatile blood flow during their cardiopulmonary bypass procedure. Both methods are standard care approaches used to maintain blood circulation while the heart is stopped during surgery. Pulsatile flow is generated by varying the pump rate to create pulses, while non-pulsatile flow uses a constant pump rate. The study does not involve masking or blinding. During the study, participants will be monitored from the time they enter the intensive care unit after surgery for up to seven days to assess kidney injury and other outcomes. Researchers will track acute kidney injury, blood transfusions, platelet counts, and mortality up to 30 days after surgery. The study will also observe the use and discontinuation of bypass modes and monitor safety. The total participation timeline includes the surgery and follow-up assessments in the hospital.
CONDITIONS
Brief Title
Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent
- Scheduled for elective cardiac surgery with cardiopulmonary bypass
- Age between 18 and 85 years
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Surgery day and up to 7 days post-surgery
Participants undergo cardiac surgery with cardiopulmonary bypass using either pulsatile or non-pulsatile blood flow during the procedure.
Monitoring during surgery and intensive care unit stay
Post-operative Follow-up
Duration - Up to 30 days after surgery
Participants are monitored for acute kidney injury and other outcomes after surgery until hospital discharge or up to 30 days.
Visits during intensive care unit stay and hospital discharge assessments
Trial Site Locations
Total: 1 location
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
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Research Team
N
Nathan J Clendenen, MD,MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
KDIGO clinical practice guidelines for acute kidney injury.
Arif Khwaja
https://pubmed.ncbi.nlm.nih.gov/22890468Pulsatile Perfusion during Cardiopulmonary Bypass: A Literature Review.
Aileen Tan, Caroline Newey, Florian Falter
https://pubmed.ncbi.nlm.nih.gov/36380831