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Recruiting NCT06349577

Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury

No phase Interventional Acute Kidney Injury Hemolysis Thrombocytopenia Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-pulsatile blood flow, Pulsatile blood flow.
Who it may be relevant to
Registry conditions: Acute Kidney Injury, Hemolysis, Thrombocytopenia, Surgery. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Randomized Controlled Trial

Overview

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.

Detailed description

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.

Interventions

  • Other Non-pulsatile blood flow
    Non-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass
  • Other Pulsatile blood flow
    Pulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass

Primary outcome measures

  • Acute kidney injury [Time frame: From intensive care unit admission after surgery up to 7 days]
Secondary outcome measures (5)
  • Acute kidney injury risk score [Time frame: On admission to the intensive care unit after surgery up to 24 hours after intensive care unit arrival]
  • Red blood cell units transfused [Time frame: After cardiopulmonary bypass up to 24 hours after intensive care unit arrival]
  • Platelet nadir [Time frame: On admission to the intensive care unit after surgery up to 7 days]
  • Discontinuation rate of cardiopulmonary bypass mode [Time frame: During cardiopulmonary bypass]
  • 30-day mortality [Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Colorado Hospital — Aurora

Publications

  • Demirjian S, Bashour CA, Shaw A, Schold JD, Simon J, Anthony D, Soltesz E, Gadegbeku CA. Predictive Accuracy of a Perioperative Laboratory Test-Based Prediction Model for Moderate to Severe Acute Kidney Injury After Cardiac Surgery. JAMA. 2022 Mar 8;327(10):956-964. doi: 10.1001/jama.2022.1751. PMID 35258532
  • Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available. PMID 22890468
  • Tan A, Newey C, Falter F. Pulsatile Perfusion during Cardiopulmonary Bypass: A Literature Review. J Extra Corpor Technol. 2022 Mar;54(1):50-60. doi: 10.1182/ject-50-60. PMID 36380831

Identifiers

NCT: NCT06349577 · 23-0921 · 5K23HL151882

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗