Optimizing Pulsatility During Cardiopulmonary Bypass
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Endothelial Dysfunction, Acute Kidney Injury. Basic parameters: 50 years — 70 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: Prospective Observational Study
Overview
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.
Primary outcome measures
- Endothelial function [Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
Secondary outcome measures (12)
- Acute kidney injury [Time frame: From intensive care unit admission after surgery to intensive care unit discharge, up to 7 days]
- Renal blood flow velocity [Time frame: Intra-operative time point: after cardiopulmonary bypass, up to 12 hours]
- Acute kidney injury risk [Time frame: Measured 4 hours after the end of cardiopulmonary bypass, up to 12 hours]
- Perioperative death [Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
- Myocardial infarction [Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
- Stroke [Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
- New renal failure requiring renal replacement therapy [Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
- Re-exploration for bleeding [Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
- Post-operative sepsis [Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
- New onset atrial fibrillation [Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
- Post-operative blood loss [Time frame: From intensive care unit admission to 24 hours after intensive care unit admission, up to 24 hours]
- Duration of mechanical ventilation [Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Colorado Hospital — Aurora
Identifiers
NCT: NCT05344573 · 20-2465 · K23HL151882