Recruiting

Pulsatile Cardiopulmonary Bypass for Acute Kidney Injury Reduction in Cardiac Surgery

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Study Aim

This study aims to observe how pulsatile cardiopulmonary bypass affects the endothelial function, specifically the percent change in flow mediated dilation of the brachial artery, in patients undergoing cardiac surgery.

What is being collected

Data Collection

Collected from today forward - Prospective
No DNA Sample
Who is being recruted

Urogenital Diseases+5

+ Female Urogenital Diseases and Pregnancy Complications

+ Kidney Diseases

From 50 to 70 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2022
See protocol details

Summary

Principal SponsorUniversity of Colorado, Denver
Study ContactNathan J Clendenen, MD, MS
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 5, 2022

Actual date on which the first participant was enrolled.

Cardiac surgery is a common but high-risk procedure that often involves the use of a heart-lung machine, or cardiopulmonary bypass (CPB). This machine helps to pump blood during the operation, but it can contribute to surgical risks by causing endothelial dysfunction and acute kidney injury (AKI). This happens because the machine typically generates a non-pulsatile blood flow, which is not normal and can lead to poor oxygen delivery to tissues. This study aims to observe if using a pulsatile blood flow in the CPB machine can improve endothelial function and reduce the risk of AKI. This is important because AKI can increase the risk of death after cardiac surgery, and over 400,000 people undergo surgery with CPB each year in the United States. In this observational study, patients undergoing cardiac surgery with CPB will be watched closely. Some patients will receive pulsatile CPB, while others will receive non-pulsatile CPB. The study will then compare the percent change in the flow mediated dilation of the brachial artery after cardiac surgery between these two groups. This measurement is an indicator of endothelial function, which is the main focus of the study. The goal is to see if pulsatile CPB can improve endothelial function and potentially reduce the risk of AKI.

Official TitleOptimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Prospective Observational Study
NCT05344573
Principal SponsorUniversity of Colorado, Denver
Study ContactNathan J Clendenen, MD, MS
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

66 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 50 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic DiseasesRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesAcute Kidney Injury

Criteria

3 inclusion criteria required to participate
Age 50 to 70

Able to provide informed consent

Scheduled for elective cardiac surgery with cardiopulmonary bypass

8 exclusion criteria prevent from participating
Patients undergoing emergency procedures

Diagnosed with sepsis

Experiencing delirium

Experiencing hemodynamic instability (heart rate > 100 and systolic blood pressure < 90)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Colorado Hospital

Aurora, United StatesOpen University of Colorado Hospital in Google Maps
Recruiting
One Study Center