protocolSection identificationModule nctId: NCT06349577, orgStudyIdInfo id: 23-0921, secondaryIdInfos id: 5K23HL151882, type: NIH, link: https://reporter.nih.gov/quickSearch/5K23HL151882, briefTitle: Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-10, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: 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., conditionsModule conditions: Acute Kidney Injury, conditions: Hemolysis, conditions: Thrombocytopenia, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1100, type: ESTIMATED, armsInterventionsModule interventions name: Non-pulsatile blood flow, interventions name: Pulsatile blood flow, outcomesModule primaryOutcomes measure: Acute kidney injury, secondaryOutcomes measure: Acute kidney injury risk score, secondaryOutcomes measure: Red blood cell units transfused, secondaryOutcomes measure: Platelet nadir, secondaryOutcomes measure: Discontinuation rate of cardiopulmonary bypass mode, secondaryOutcomes measure: 30-day mortality, otherOutcomes measure: Myocardial infarction, otherOutcomes measure: Stroke, otherOutcomes measure: Renal failure requiring renal replacement therapy, otherOutcomes measure: Re-exploration for bleeding, otherOutcomes measure: Sepsis, otherOutcomes measure: New onset atrial fibrillation, otherOutcomes measure: Duration of mechanical ventilation, otherOutcomes measure: Post-operative delirium, otherOutcomes measure: Post-operative hospital length of stay, otherOutcomes measure: New requirement for mechanical circulatory support, otherOutcomes measure: Intra-operative red blood cell transfusion in units, otherOutcomes measure: Post-operative red blood cell transfusion in units, otherOutcomes measure: Post-operative platelet transfusion in units, otherOutcomes measure: Post-operative plasma transfusion in units, otherOutcomes measure: Post-operative cryoprecipitate transfusion in units, otherOutcomes measure: Intra-operative platelet transfusion in units, otherOutcomes measure: Intra-operative plasma transfusion in units, otherOutcomes measure: Intra-operative cryoprecipitate transfusion in units, otherOutcomes measure: New onset of acute lung injury, otherOutcomes measure: New onset of left ventricular systolic dysfunction, otherOutcomes measure: New onset of right ventricular systolic dysfunction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado Hospital, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False