protocolSection identificationModule nctId: NCT06279793, orgStudyIdInfo id: MODIFYCSX, briefTitle: Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients., acronym: MODIFYCSX, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: GCP-Service International West GmbH, class: INDUSTRY, collaborators name: Charite University, Berlin, Germany, collaborators name: Wuerzburg University Hospital, descriptionModule briefSummary: The proposing study is a randomized, double-blind, controlled trial of about 120 patients in 10 centers in Germany. This trial will be started in Germany and recruited mainly at powerful German heart centers only.In this prospective randomized controlled blinded multicenter trial, a total of 120 high-risk cardiac surgery patients will receive either standard of care + OMEGAVEN at 0.20 g/kg ideal body weight (IBW) versus placebo + standard of care., conditionsModule conditions: Cardiac Surgery, conditions: High Risk Patients, conditions: Intensive Care Unit, conditions: Cardiopulmonary Bypass, conditions: Valve Surgeries, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomization will be stratified by site, employing a web-based system using a 1:1 ratio to either intravenous FO- based lipid emulsion (Omegaven®), or placebo., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Researchers and clinical staff will be blinded to study intervention allocation. Unblinded delegate at each site will be able to prepare and dispense the investigational drug or placebo., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Long-chain n-3 fatty acids, interventions name: Intravenous 0.9% Sodium Chloride, outcomesModule primaryOutcomes measure: Atrial fibrillation, secondaryOutcomes measure: Weaning from cardiopulmonary bypass (CPB), secondaryOutcomes measure: Time to discharge alive, secondaryOutcomes measure: Persistent Organ Dysfunction + Death, secondaryOutcomes measure: Days alive and out of hospital, secondaryOutcomes measure: Hospital length of stay, secondaryOutcomes measure: ICU length of stay, secondaryOutcomes measure: Simplified Acute Physiology Score, secondaryOutcomes measure: Therapeutic Intervention Scoring System, secondaryOutcomes measure: ICU and Hospital Readmission rates, secondaryOutcomes measure: Delta Sequential Organ Failure Assessment Score (SOFA) Score, secondaryOutcomes measure: Mechanical ventilation, secondaryOutcomes measure: Stroke, secondaryOutcomes measure: Acute Kidney Injury, secondaryOutcomes measure: Infections rate, secondaryOutcomes measure: Clinical frailty scale, secondaryOutcomes measure: Development of delirium, secondaryOutcomes measure: Survival status, secondaryOutcomes measure: Physical activity assessment, secondaryOutcomes measure: Quality of Life (SF-36), secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Postoperative bleeding, otherOutcomes measure: Optional-Ultrasound measurement, otherOutcomes measure: Optional-Functional Status Score for Intensive Care Unit, otherOutcomes measure: Optional-Short Physical Performance Battery test, otherOutcomes measure: Optional-Hand grip dynamometer, otherOutcomes measure: Optional-Hand held dynamometer, otherOutcomes measure: Optional-Manual Muscle Testing, otherOutcomes measure: Optional-Left ventricular ejection function, otherOutcomes measure: Optional-Markers of inflammation, otherOutcomes measure: Optional-Hemodynamics, otherOutcomes measure: Sub-study, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RWTH Aachen University, status: NOT_YET_RECRUITING, city: Aachen, country: Germany, contacts name: Moritz Immohr, M.D, role: CONTACT, email: mimmohr@ukaachen.de, contacts name: Aileen Hill, M.D, role: CONTACT, email: ahill@ukaachen.de, geoPoint lat: 50.77664, lon: 6.08342, locations facility: Charité Universitätsmedizin Berlin, status: NOT_YET_RECRUITING, city: Berlin, country: Germany, contacts name: Sascha Ott, M.D, role: CONTACT, email: sascha.ott@dhzc-charite.de, contacts name: Maren Kleine-Brüggeney, M.D, role: CONTACT, email: maren.kleine-brueggeney@dhzc-charite.de, geoPoint lat: 52.52437, lon: 13.41053, locations facility: University of Bonn, status: NOT_YET_RECRUITING, city: Bonn, country: Germany, contacts name: Markus Velten, M.D, role: CONTACT, email: markus.velten@ukbonn.de, contacts name: Maria Wittmann, M.D, role: CONTACT, email: Maria.Wittmann@ukbonn.de, geoPoint lat: 50.73438, lon: 7.09549, locations facility: Universität Göttingen, status: NOT_YET_RECRUITING, city: Göttingen, country: Germany, contacts name: Reiner Wäschle, M.D, role: CONTACT, email: Reiner.Waeschle@med.uni-goettingen.de, contacts name: Anselm Bräuer, M.D., role: CONTACT, email: abraeue@gwdg.de, geoPoint lat: 51.53443, lon: 9.93228, locations facility: University Medical Center Schleswig-Holstein, status: NOT_YET_RECRUITING, city: Kiel, country: Germany, contacts name: Elke Gunnar, M.D, role: CONTACT, email: Gunnar.Elke@uksh.de, contacts name: Matthias Lindner, M.D, role: CONTACT, email: Matthias.Lindner@uksh.de, geoPoint lat: 54.32133, lon: 10.13489, locations facility: University of Muenster, status: RECRUITING, city: Münster, country: Germany, contacts name: Alexander Zarbock, M.D, role: CONTACT, email: zarbock@uni-muenster.de, contacts name: Carola Wempe, M.D, role: CONTACT, email: Carola.Wempe@ukmuenster.de, geoPoint lat: 51.96236, lon: 7.62571, hasResults: False