An interventional study of Non-pulsatile blood flow and Pulsatile blood flow in Acute Kidney Injury, Hemolysis and Thrombocytopenia, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Prevention
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.
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.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 1,100 is above the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Non-pulsatile blood flow during cardiopulmonary bypass
Other: Non-pulsatile blood flow
Pulsatile blood flow during cardiopulmonary bypass
Other: Pulsatile blood flow
Non-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass
Pulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass
Acute kidney injury
Stage 1 (mild), 2 (moderate), or 3 (severe) acute kidney injury according to the Kidney Disease Improving Global Outcomes creatinine criteria (stage 1 = 1.5 to 1.9 times baseline or greater than or equal to 0.3 milligrams per deciliter increase in serum creatinine, stage 2 = 2.0 to 2.9 times baseline in serum creatinine, stage 3 = 3.0 times baseline or increase in serum creatinine greater than or equal to 4.0 milligrams per deciliter or initiation of renal replacement therapy
Time frame: From intensive care unit admission after surgery up to 7 days
Acute kidney injury risk score
Demirjian Perioperative Laboratory Test-Based Prediction Model for Moderate to Severe Acute Kidney Injury After Cardiac Surgery in percent predicted risk
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
Number of allogenic red blood cell units transfused after cardiopulmonary bypass
Time frame: After cardiopulmonary bypass up to 24 hours after intensive care unit arrival
Platelet nadir
Lowest platelet count after cardiopulmonary bypass
Time frame: On admission to the intensive care unit after surgery up to 7 days
Discontinuation rate of cardiopulmonary bypass mode
Discontinuation rate of pulsatile or non-pulsatile cardiopulmonary bypass mode
Time frame: During cardiopulmonary bypass
30-day mortality
All cause mortality
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Myocardial infarction
Myocardial infarction by clinical diagnosis
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Stroke
Stroke by clinical diagnosis
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Renal failure requiring renal replacement therapy
New diagnosis of 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
Surgical re-exploration for bleeding
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Sepsis
Diagnosed by positive blood culture
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
New onset atrial fibrillation
Clinical diagnosis of new onset atrial fibrillation
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Duration of mechanical ventilation
Duration of mechanical ventilation
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative delirium
Post-operative determined by the Confusion Assessment Method for the Intensive Care Unit
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative hospital length of stay
Post-operative hospital length of stay
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
New requirement for mechanical circulatory support
New requirement for mechanical circulatory support
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Intra-operative red blood cell transfusion in units
Intra-operative red blood cell transfusion in units
Time frame: During the intra-operative time period, up to 12 hours
Post-operative red blood cell transfusion in units
Post-operative red blood cell transfusion in units
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative platelet transfusion in units
Post-operative platelet transfusion in units
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative plasma transfusion in units
Post-operative plasma transfusion in units
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative cryoprecipitate transfusion in units
Post-operative cryoprecipitate transfusion in units
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Intra-operative platelet transfusion in units
Intra-operative platelet transfusion in units
Time frame: During the intra-operative time period, up to 12 hours
Intra-operative plasma transfusion in units
Intra-operative plasma transfusion in units
Time frame: During the intra-operative time period, up to 12 hours
Intra-operative cryoprecipitate transfusion in units
Intra-operative cryoprecipitate transfusion in units
Time frame: During the intra-operative time period, up to 12 hours
New onset of acute lung injury
Diagnosis of acute lung injury by PaO2 to FiO2 ratio ≤ 300
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
New onset of left ventricular systolic dysfunction
New onset of left ventricular systolic dysfunction determined by a LV ejection fraction \<50%
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
New onset of right ventricular systolic dysfunction
New onset of right ventricular systolic dysfunction determined by a tricuspid annular plane systolic excursion less than 16 mm
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
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