Using pulsatile blood flow during heart surgery to prevent kidney injury
Official title: Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Randomized Controlled Trial
Run by University of Colorado, Denver · NCT06349577 · Data updated 2026-11-12
This study tests if using a pulsing blood flow during heart surgery can help protect the kidneys from injury better than the usual steady flow.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 1100 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | May 19, 2025 |
| Main results expected | April 2028 |
| Study ends | October 2028 |
| Registry record updated | May 21, 2025 |
| Trial ID | NCT06349577 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients scheduled for elective cardiac surgery that requires cardiopulmonary bypass.
✕Probably not a fit
Patients undergoing emergency procedures or those with certain medical conditions, such as sepsis or hemodynamic instability, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of pulsatile blood flow compared to non-pulsatile blood flow during cardiopulmonary bypass in reducing the incidence of acute kidney injury after cardiac surgery. Investigators will assess both the safety and clinical outcomes associated with each method of blood flow. The hypothesis is that pulsatile flow, which mimics the natural beating of the heart, may provide better kidney protection than the traditional non-pulsatile flow. The study will involve patients scheduled for elective cardiac surgery requiring cardiopulmonary bypass.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of acute kidney injury in patients undergoing cardiac surgery.
How similar studies have gone: While both pulsatile and non-pulsatile flows are standard practices, this study seeks to clarify their comparative effectiveness, making it a novel investigation in this area.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Colorado Hospital
Aurora, Colorado, United States Recruiting
Study contacts
- Principal investigator: Nathan J Clendenen, MD, MS — University of Colorado, Denver
- Study coordinator: Nathan J Clendenen, MD,MS
- Email: nathan.clendenen@cuanschutz.edu
- Phone: 3037245000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.