Cardiac Surgery Clinical Trial
Official title:
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients: a Phase II Multicenter Trial: A Double-blind, Randomized, Placebo-controlled Trial.
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.
The proposed hypothesize is that the therapeutic strategy tested in this randomized trial will decrease the occurrence of postoperative atrial fibrillation, which ultimately lead to faster time to discharge alive. This turn significantly improves the patients' mid and long-term outcomes and dramatically reduces associated healthcare related costs. Duration of intervention: until discharge from ICU, death or postoperative day 7 on ICU, whichever comes first. Treatment Group: Patients will receive Omegaven® in dose 0.20 g/kg/d. Control Group: Patients will receive 0,9% NaCl in dose 0.20 g/kg/d (placebo). Follow-up per patient: at day 30, month 3, 6, and 12 months. Primary endpoint (phase II study): The primary endpoint for this phase II clinical trial will be the presence of new onset atrial fibrillation after cardiac surgery (AFACS) until day 7 after surgery. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05054179 -
Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain
|
Phase 2/Phase 3 | |
| Completed |
NCT04051021 -
Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients
|
N/A | |
| Recruiting |
NCT04604886 -
The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients
|
N/A | |
| Recruiting |
NCT04075981 -
Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF)
|
Phase 3 | |
| Completed |
NCT04062396 -
Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction
|
N/A | |
| Recruiting |
NCT04709705 -
DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT05563662 -
SURgical Registry of ENDocarditis EuRope
|
||
| Withdrawn |
NCT03289104 -
Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX
|
N/A | |
| Completed |
NCT02964026 -
Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients
|
N/A | |
| Completed |
NCT04199039 -
Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction
|
N/A | |
| Completed |
NCT03563196 -
Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
|
||
| Completed |
NCT02471001 -
The Levels of Anaesthetics in Heart Muscle During Heart Surgery
|
N/A | |
| Completed |
NCT02325726 -
RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery.
|
N/A | |
| Completed |
NCT01246947 -
Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation
|
N/A | |
| Completed |
NCT01151254 -
Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation
|
N/A | |
| Completed |
NCT00821262 -
Sevoflurane in Cardiac Surgery
|
Phase 4 | |
| Completed |
NCT00996099 -
Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients
|
N/A | |
| Completed |
NCT00617955 -
Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates
|
N/A | |
| Completed |
NCT00337805 -
Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery
|
Phase 2/Phase 3 | |
| Completed |
NCT00336466 -
The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS)
|
Phase 2 |