Using pulsatile blood flow during heart surgery to prevent kidney injury
Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06349577 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for elective cardiac surgery that requires cardiopulmonary bypass.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aurora, Colorado
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.