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/35258532/Actively Recruiting
Led by University of Colorado, Denver · Updated on 2025-05-21
1100
Participants Needed
1
Research Sites
26 weeks
Total Duration
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
Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury
N
Nathan J Clendenen, MD,MS
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University of Colorado, Denver
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Pulsatile blood flow | Non-pulsatile blood flow |
|---|---|---|
| What it is | Variable-flow perfusion technique during cardiopulmonary bypass delivering blood in a pulsatile fashion by altering the centrifugal pump rate. | Constant-flow perfusion technique during cardiopulmonary bypass where blood is delivered in a continuous, non-pulsatile manner using a centrifugal pump. |
| Role in trial | Investigational arm designed to assess whether pulsatile perfusion reduces kidney complications post-surgery. | Serves as the standard comparator arm receiving conventional non-pulsatile perfusion during surgery. |
| Primary use or purpose | Examines whether pulsatile perfusion can better protect kidney function and reduce the risk of acute kidney injury during cardiac surgery. | Used routinely during cardiopulmonary bypass for oxygenation and circulation during cardiac surgery. |
| How it is given or performed | Blood flow is modulated to mimic natural pulsatility by altering the centrifugal pump’s speed during the bypass. | Blood is pumped continuously at a steady rate using a centrifugal pump throughout the bypass period. |
| Evidence status | Emerging evidence suggests pulsatile perfusion may improve renal perfusion and reduce risk of acute kidney injury, but definitive benefits remain under investigation. High-quality randomized data are still needed. | Long-standing evidence base as the standard approach, but recent studies question its ability to reduce post-operative complications such as acute kidney injury compared to pulsatile approaches. |
| Important limitations | Technical complexity, variation in implementation, and lack of consensus on best parameters limit widespread use. Clinical benefits over non-pulsatile flow remain to be clearly demonstrated by large randomized trials. | May be associated with greater risk of microcirculatory disturbances and is debated for its impact on organ function, especially renal outcomes. Not all patients experience complication reduction. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Sevag Demirjian, C Allen Bashour, Andrew Shaw...
https://pubmed.ncbi.nlm.nih.gov/35258532/Aileen Tan, Caroline Newey, Florian Falter
https://pubmed.ncbi.nlm.nih.gov/36380831/Arif Khwaja
https://pubmed.ncbi.nlm.nih.gov/22890468/University of Colorado, Denver
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor