Optimizing Pulsatility During Cardiopulmonary Bypass

NCT ID: NCT05344573

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-05
• Study Completion Date: 2025-07-01

Brief Summary

Cardiopulmonary bypass during cardiac surgery provides blood flow to the body during surgery but has adverse effects on different organs. Blood flow during cardiopulmonary bypass may be pulsatile or non-pulsatile, which may impact normal organ function after surgery. The study will collect data on the type of cardiopulmonary bypass used during surgery and organ function to determine if there is an association between the type of bypass and organ function.

Detailed Description

Cardiac surgery is a high-risk elective surgical procedure frequently requiring CPB in which a machine pumps blood while the surgeon operates on the heart. CPB contributes to surgical risk by causing endothelial dysfunction and acute kidney injury (AKI). Endothelial dysfunction and AKI happen because heart lung machines typically generate non-pulsatile blood flow, which is abnormal and results in impaired tissue oxygen delivery. Normal blood flow is pulsatile due intermittent contraction and relaxation of the heart during the cardiac cycle, which produces a mechanical signal that induces endothelial cells to produce nitric oxide. Without nitric oxide, blood flow does not penetrate as deeply into organs such as the kidneys which leads to acute kidney injury. AKI increases mortality 10-fold after cardiac surgery placing many people at risk since over 400,000 people have surgery with CPB each year in the United States. Thus, pulsatile CPB may influence endothelial function and renal blood flow after cardiac surgery. This study will observe patients undergoing cardiac surgery with CPB and compare patients who receive pulsatile or non-pulsatile CPB.

Conditions

Endothelial Dysfunction; Acute Kidney Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-pulsatile cardiopulmonary bypass

Subjects who undergo cardiac surgery with non-pulsatile cardiopulmonary bypass

No interventions assigned to this group

Pulsatile cardiopulmonary bypass

Subjects who undergo cardiac surgery with pulsatile cardiopulmonary bypass

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathan J Clendenen, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver | Anschutz

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nathan J Clendenen, MD, MS

Role: CONTACT

nathan.clendenen@cuanschutz.edu

(303) 724-5375

Facility Contacts

Nathan Clendenen, MD MS

Role: primary

nathan.clendenen@cuanschutz.edu

303-724-5000

Other Identifiers

K23HL151882

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-2465

Identifier Type: -

Identifier Source: org_study_id