Optimizing blood flow during heart surgery
Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Prospective Observational Study
This study is trying to see if using a pulsing blood flow during heart surgery helps patients recover better and have fewer problems with their organs compared to a steady flow.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 66 (estimated) |
| Ages | 50 Years to 70 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05344573 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of pulsatile versus non-pulsatile blood flow during cardiopulmonary bypass (CPB) in patients undergoing elective cardiac surgery. It aims to determine the association between the type of CPB used and subsequent organ function, particularly focusing on endothelial dysfunction and acute kidney injury. By collecting data on patients' organ function post-surgery, the study seeks to understand how different blood flow patterns impact recovery and overall outcomes. The findings could provide insights into optimizing surgical techniques to improve patient safety and recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 50 to 70 scheduled for elective cardiac surgery requiring cardiopulmonary bypass.
Not a fit: Patients undergoing emergency procedures or those with severe comorbidities such as sepsis or hemodynamic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced risk of acute kidney injury for patients undergoing cardiac surgery.
How similar studies have performed: While the approach of comparing pulsatile and non-pulsatile CPB has been explored, this study aims to provide more definitive data on its impact on organ function, making it a valuable addition to existing literature.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 50 to 70 * Able to provide informed consent * Scheduled for elective cardiac surgery with cardiopulmonary bypass Exclusion Criteria: * Patients undergoing emergency procedures * Diagnosed with sepsis * Experiencing delirium * Experiencing hemodynamic instability (heart rate \> 100 and systolic blood pressure \< 90) * Patients with a mechanical circulatory support device * Requiring vasoactive medications before surgery * Patients with a reduced left ventricular ejection fraction (less than 50%) * Patients with a contraindication to transesophageal echocardiography
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 | Anschutz
- Study coordinator: Nathan J Clendenen, MD, MS
- Email: nathan.clendenen@cuanschutz.edu
- Phone: (303) 724-5375
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.