Intravenous Fish Oil based Lipid Emulsion as Pharmaconutrient Strategy in High-Risk Cardiac Surgery Patients: a Phase II Dosing Study

Phase 1

Conditions: Given the recently meta-analyzed data from previous RCTs about fish oil , we hypothesize that the provision of intravenous (i.v.) FO (0.20 g/kg and 0.50 g/kg) to cardiac surgery patients may reduce the development of postoperative infections and organ dysfunctions through modulation of cytokines and chemokine release that regulate the activity of various immune cell populations.
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2016-003902-14-DE

Lead Sponsor: RWTH Aachen University, represented by the Clinical Trial Center (CTC-A)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine safety and efficacy of i.v. fish oil doses of 0.20 g/kg/d and 0.50 g/kg/d compared to a control group in high risk patient undergoing cardiac surgery.;Secondary Objective: To assess the effect of fish oil application on the peri-operative systemic inflammatory response and immune status. ;Primary end point(s): - safety and efficacy<br>- feasibility<br>;Timepoint(s) of evaluation of this end point: Depending on end point (daily evaluation)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ?Anti-inflammatory response<br>?Oxidative stress<br>?Inflammatory response on the immune system<br>?Effect on body’s immune competence<br>?Immune phenotype and activation of immune cells<br>?Safety parameters in blood<br>?Pharmacokinetic profile<br>?Change in SOFA score<br>?ICU length of stay<br>?Hospital length of stay<br>?Length of ventilation<br>?Number of infection<br>?Persistent Organ Dysfunction+death (POD+death) <br>?30-day mortality<br>?Hospital mortality rate<br>?Quality of Life after 3 and 6 month<br>?Membrane incorporation of PUFAs in immune cells<br>?activation of protective survival kinases such as ERK1/2 and Akt<br>?adverse and serious adverse events<br><br>;Timepoint(s) of evaluation of this end point: during the ICU stay, at follow up visit day 30 (30-day mortality), month 3 (SF36) and month 6 (SF36)