Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients.

Phase 2

Recruiting

• Conditions: Intensive Care Unit; Cardiac Surgery; High Risk Patients; Cardiopulmonary Bypass; Valve Surgeries
• Interventions: Drug: Long-chain n-3 fatty acids; Drug: Intravenous 0.9% Sodium Chloride

• Registration Number: NCT06279793
• Lead Sponsor: GCP-Service International West GmbH

Brief Summary

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.

Detailed Description

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-13
• Study Start: 2024-02-15
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Written informed consent prior to study participation

2. Adult patients (≥ 18 years)

3. Patients scheduled to undergo elective cardiac surgery with the use of cardiopulmonary bypass (CPB), who are defined as high risk based on having (i) combined valve/coronary artery bypass graft (CABG) or multiple valve surgeries, or combined cardiac/aortic surgical procedures and (ii) one of the following additional risk factors:

   1. a high perioperative risk profile, defined as predicted operative mortality of ≥ 8% (European System for Cardiac Operative Risk Evaluation, EuroSCORE II).
   2. Age >70
   3. Clinical Frailty Score 4 or more
   4. Urgent surgery (defined as to be performed within 24-48 hours after admission)
   5. Left ventricular ejection fraction <35%

Read More

Exclusion Criteria

1. Known hypersensitivity to fish oil (FO)/ fish products or egg protein
2. Pregnancy or lactation period
3. Previous history of atrial fibrillation, atrial flutter and/or atrial tachyarrhythmia
4. Inability or unwillingness of individual to give written informed consent
5. Not expected to survive an additional 48 hours from screening evaluation
6. Lack of commitment to full, aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated "Do not Resuscitate" (DNR) acceptable)
7. Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma
8. Patients receiving and extracorporeal mechanical assist device (e.g. extracorporal life support systems [ECLS], or intra-aortic ballon pump [IABP]) or for advanced heart failure therapies (e.g. platelet aggregation inhibitors [TAH], ventricular assist devices [VAD])
9. Enrolment in anyinterventional trial within the last 30 days
10. Already receiving FO-containing medical nutrition products
11. Severe malnutrition (as defined by the BMI<18.5)
12. Severe liver dysfunction defined by Child Pugh Class C.
13. Severe chronic kidney dysfunction defined by the National Kidney Foundation (NKF) stage 4 and 5 by using the glomerular filtration rate (GFR < 30ml/min)1
14. Known severe coagulation disorder

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Long-chain n-3 fatty acids	Patients will receive 0.20 g fish oil/kg BW/d (≙2 mL Omegaven®/kg BW/d).
Control group	Intravenous 0.9% Sodium Chloride	Patients will receive 0,9% NaCl in volume 2 mL/kg BW/d (placebo).

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation	Days 0-7	The primary objective is to demonstrate superiority of fish oil (FO) compared to placebo in the prevention of atrial fibrillation (AF) until 7 days after surgery. This clinical endpoint is assessed as part of the clinical practice.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Day 0 to 12 months	AEs leading to discontinuation/AEs at least possibly related to the IMP/SAEs
Mechanical ventilation	Day 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30	Duration of mechanical ventilation
Delta Sequential Organ Failure Assessment Score (SOFA) Score	Days 0-7	A scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category.
Stroke	Days 0-7	Incidence of stroke
Inotropics/vasopressors	Days 0-7, ICU discharge (approximately 3-4 days after surgery)	Duration and dosages of inotropic/vasopressor support
Acute Kidney Injury	Days 0-7	Kidney Disease: Improving Global Outcomes \[KDIGO\] stages 1-3
Vasoactive-Inotropic Score (VIS)	Days 0-7	Vasoactive-Inotropic Score (VIS)
Infections rate	Days 0-7	Time to and number of infections
Development of delirium	Days 0-7	Assessed by the CAM ICU score
Therapeutic Intervention Scoring System	Days 0-7	A method for measuring workload and calculating costs in the ICU
Survival status	ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30, months 3, 6, and 12	Overall survival
Quality of Life (SF-36)	Screening, day 30, 3, 6, and 12 months	To measure the quality of life
Postoperative bleeding	Days 0-7	Bleeding after surgery
ICU length of stay	ICU discharge (approximately 3-4 days after surgery)	Number of days alive in the ICU
Clinical frailty scale	Screening, day 30, 3 months	A 9-point scale that quantifies frailty based on function in individual patients
Hospital length of stay	Hospital discharge (approximately 1-2 weeks after surgery)	Number of days alive in the hospital
Physical activity assessment	Screening, day 30, 3 and 6 months	Katz activities of daily living (ADL) and Lawton's Instrumental ADL (IADL)
Days alive and out of hospital	Day 30, 3, 6, and 12 months	Time to be alive and discharge from hospital
Time to discharge alive	ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)	Time to be alive and discharge from ICU/hospital
Persistent Organ Dysfunction + Death	Days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30	Requiring supportive technologies during the convalescent phase of critical illness
Weaning from cardiopulmonary bypass (CPB)	Day 0 (during surgery)	Number of attempts to wean from CPB during surgery
Simplified Acute Physiology Score	Days 0-7	Estimates the probability of mortality for ICU patients on admission
ICU and Hospital Readmission rates	Day 30, 3, 6, and 12 months	Readmission to ICU and hospital

Trial Locations

Locations (5)

University Hospital Goettingen; 🇩🇪 Göttingen, Germany

University Hospital Muenster; 🇩🇪 Muenster, Germany

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

University of Bonn; 🇩🇪 Bonn, Germany

University Medical Center Schleswig-Holstein; 🇩🇪 Kiel, Germany