Optimizing Pulsatility During Cardiopulmonary Bypass

NCT05344573 | Recruiting DMC

• 2 other identifiers: 20-2465K23HL151882
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction; Acute Kidney Injury

Keywords

Endothelial function; Acute Kidney Injury; Cardiopulmonary bypass; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Endothelial function

  Percent change in flow mediated dilation of the brachial artery after cardiac surgery

  From intensive care unit admission after surgery to hospital discharge, up to 30 days

Secondary Outcomes (29)

• Acute kidney injury

  From intensive care unit admission after surgery to intensive care unit discharge, up to 7 days

• Renal blood flow velocity

  Intra-operative time point: after cardiopulmonary bypass, up to 12 hours

• Acute kidney injury risk

  Measured 4 hours after the end of cardiopulmonary bypass, up to 12 hours

• Perioperative death

  From intensive care unit admission after surgery to hospital discharge, up to 30 days

• Myocardial infarction

  From intensive care unit admission after surgery to hospital discharge, up to 30 days

Study Arms (2)

Non-pulsatile cardiopulmonary bypass

Subjects who undergo cardiac surgery with non-pulsatile cardiopulmonary bypass

Pulsatile cardiopulmonary bypass

Subjects who undergo cardiac surgery with pulsatile cardiopulmonary bypass

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients aged 50 to 70 years scheduled for elective cardiac surgery with cardiopulmonary bypass

You may qualify if:

• Age 50 to 70
• Able to provide informed consent
• Scheduled for elective cardiac surgery with cardiopulmonary bypass

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Vascular tissue Bone marrow

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Nathan J Clendenen, MD, MS

  University of Colorado Denver | Anschutz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathan J Clendenen, MD, MS

CONTACT

(303) 724-5375; nathan.clendenen@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: April 25, 2022
• Study Start: July 5, 2022
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)