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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2027-02-28

Brief Summary

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The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany.

A total of 120 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight (BW) + standard of care versus same volume of placebo (NaCl) + standard of care.

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Detailed Description

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The proposed hypothesis is that the therapeutic strategy tested in this randomized trial will decrease the occurrence of postoperative atrial fibrillation, which ultimately leads to faster time to discharge alive. This in 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 0.20 g fish oil/kg BW/d (≙ 2 mL Omegaven®/kg BW/d).

Control Group: Patients will receive 0,9% NaCl in dose 2 mL/kg BW/d (placebo).

Follow-up per patient: at day 30, months 3, 6, and 12.

Primary endpoint (Phase II study):

The primary endpoint for this phase II clinical trial is be the onset and occurence of atrial fibrillation after cardiac surgery (AFACS) until day 7 after surgery (on ICU and normal ward).

Conditions

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Intensive Care Unit Coronary Artery Bypass Grafting (CABG) High Risk Patients Cardiopulmonary Bypass Elective Cardiac Surgery Valvular Heart Surgery Multiple Valve Surgeries Combined Cardiac Procedures Aortic Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization will be stratified by site, employing a web-based system using a 1:1 ratio to either intravenous fish oil-based lipid emulsion (Omegaven®), or placebo.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Patients as well as clinical staff and outcome assessors not involved in the study will be blinded to study intervention allocation.

Study Groups

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Treatment group

Patients will receive 0.20 g fish oil/kg BW/d (≙2 mL Omegaven®/kg BW/d).

Group Type EXPERIMENTAL

Fish Oil

Intervention Type DRUG

Omegaven® is a 10% fish oil emulsion with a high percentage of long-chain n-3 fatty acids - mainly eicosapentaenoic acid and docosahexaenoic acid. It optimises the fatty acid pattern in parenteral nutrition and is a source of polyunsaturated n-3 fatty acids as cell membrane components and precursors for eicosanoids.

Omegaven® is manufactured by Fresenius-Kabi, Germany and is available in 100 mL bottles for study purpose.

Each 100 mL of Omegaven® contains 10 g of fish oil (0.1 g/mL).

Timeframe: Day -1: 0.20 g fish oil/kg BW/d (the treatment should be started 24 to 3 h before surgery, can be given as 3-6 hours infusion); intraoperative day 0: no dose; postoperative day 0: 0.20 g fish oil/kg BW/d; postoperative days 1 to max. 7): 0.20 g fish oil/kg BW/d

Control group

Patients will receive 0,9% NaCl in volume 2 mL/kg BW/d (placebo).

Group Type PLACEBO_COMPARATOR

Intravenous 0.9% Sodium Chloride

Intervention Type DRUG

Intravenous 0.9% Sodium Chloride (volume 2 mL/kg BW/d) provided at the same timepoints as the intervention.

Interventions

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Fish Oil

Omegaven® is a 10% fish oil emulsion with a high percentage of long-chain n-3 fatty acids - mainly eicosapentaenoic acid and docosahexaenoic acid. It optimises the fatty acid pattern in parenteral nutrition and is a source of polyunsaturated n-3 fatty acids as cell membrane components and precursors for eicosanoids.

Omegaven® is manufactured by Fresenius-Kabi, Germany and is available in 100 mL bottles for study purpose.

Each 100 mL of Omegaven® contains 10 g of fish oil (0.1 g/mL).

Timeframe: Day -1: 0.20 g fish oil/kg BW/d (the treatment should be started 24 to 3 h before surgery, can be given as 3-6 hours infusion); intraoperative day 0: no dose; postoperative day 0: 0.20 g fish oil/kg BW/d; postoperative days 1 to max. 7): 0.20 g fish oil/kg BW/d

Intervention Type DRUG

Intravenous 0.9% Sodium Chloride

Intravenous 0.9% Sodium Chloride (volume 2 mL/kg BW/d) provided at the same timepoints as the intervention.

Intervention Type DRUG

Other Intervention Names

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Omegaven® Saline Infusion

Eligibility Criteria

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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 CPB, who are defined as high risk based on having (i) one of the following surgical procedures: valvular heart surgery only, CABG, combined valve and CABG, multiple valve surgeries, combined cardiac procedures, aortic surgical procedures (aortic arch and/or descending aorta; aortic valve+ascending aorta) and (ii) at least one of the following additional risk factors: (a) a high perioperative risk profile, defined as predicted operative mortality of ≥8% (EuroSCORE II), (b) age ≥70, (c) Clinical Frailty Score 4 or more, (d) urgent surgery (defined as to be performed within 24-48 hours after admission), (e) left ventricular ejection fraction \<35%

Exclusion Criteria

1. Known hypersensitivity to fish oil/fish products or egg protein
2. Pregnancy or lactation period
3. Previous history of chronic 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 extracorporeal mechanical assist device (e.g. ECLS, or IABP) or advanced heart failure therapies (e.g. TAH, 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)
14. Known severe coagulation disorder

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No