Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-19

Study Completion Date

2028-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective is to determine the effectiveness of pulsatile flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery. Investigators will also evaluate the safety and impact of pulsatile flow on clinical outcomes compared to non-pulsatile flow during cardiopulmonary bypass.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neutrophil, Lymphocyte and Platelet as a Predictor for AKI and Mortality

NCT02916043

Acute Kidney Injury

COMPLETED

Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction.

NCT02836899

Acute Kidney Injury

ACTIVE_NOT_RECRUITING PHASE3

Parameters of Cerebral Perfusion

NCT02806492

Cerebral Perfusion Cerebral Oxygenation Cardiopulmonary Bypass

COMPLETED NA

Perioperative Blood Pressure Screening to Improve Long-term Cardiovascular Health

NCT03634813

Blood Pressure

COMPLETED NA

A Monitoring System Based on the Multifactorial Dynamic Perfusion Index to Predict and Prevent the Onset of Postoperative Acute Kidney Injury After Cardiac Surgery, Based on a Dynamic Collection of Hemodynamic and Clinical Parameters During Cardiopulmonary Bypass

NCT06786416

Cardiac Diseases Cardio-pulmonary Bypass Acute Kidney Injury +4 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass for cardiac surgery are both considered standard of care and allow surgeons to operate on the heart without movement. Pulsatile cardiopulmonary bypass produces variations in blood flow to produce a pulse similar to a normal beating heart. Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass are approved as safe and effective ways to provide perfusion during cardiac surgery, but it is unknown whether there are differences in clinical outcomes after surgery. Acute kidney injury is common after cardiac surgery and may be caused by inadequate perfusion during cardiopulmonary bypass.

Specific Aim: The purpose of this study is to determine the effectiveness of pulsatile blood flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.

Hypothesis: Pulsatile blood flow during cardiopulmonary bypass will reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Kidney Injury Hemolysis Thrombocytopenia Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-pulsatile blood flow

Non-pulsatile blood flow during cardiopulmonary bypass

Group Type ACTIVE_COMPARATOR

Non-pulsatile blood flow

Intervention Type OTHER

Non-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass

Pulsatile blood flow

Pulsatile blood flow during cardiopulmonary bypass

Group Type ACTIVE_COMPARATOR

Pulsatile blood flow

Intervention Type OTHER

Pulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non-pulsatile blood flow

Non-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass

Intervention Type OTHER

Pulsatile blood flow

Pulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No