EUCTR2016-003902-14-DEActive, not recruitingPhase 1
Intravenous Fish Oil based Lipid Emulsion as Pharmaconutrient Strategy in High-Risk Cardiac Surgery Patients: a Phase II Dosing Study - Modify CSx
RWTH Aachen University, represented by the Clinical Trial Center (CTC-A)0 sitesStarted: February 3, 2017Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1) Age = 18 years scheduled to undergo elective cardiac surgery with the use of CPB and cardioplegic Arrest:
- •Included patients should exhibit a significantly increased perioperative risk profile defined as a predictive operative mortality EuroSCORE 5% or by complex/combined surgical procedures.
- •2) Written informed consent prior to study participation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 144
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 144
Exclusion Criteria
- •1) Known hypersensitivity to fish oil/ fish products or egg protein
- •2) Emergency open heart surgery
- •3) Severe dyslipidemia (triglycerides > 400 mg/dl)
- •4) Pregnancy or lactation period
- •5) Inability or unwillingness of individual to give written informed consent
- •6) Simultaneous participation in another clinical trial
- •7) Not study related fish oil supplementation
- •8) Severe renal or hepatic insufficiency (Patients with Cirrhosis Child’s Class C Liver Disease)
- •9) Not expected to survive an additional 48 hours from screening evaluation
- •10) Lack of commitment to full, aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated DNR acceptable)
- •11) Patients admitted with Diabetic Ketoacidosis or non-ketotic hyperosmolar coma
- •12) Patients receiving and extracorporeal mechanical assist device (e.g. ECLS, or IABP) or for advanced heart failure therapies (e.g. TAH, VAD)
Investigators
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