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

ConditionsIntensive Care UnitCoronary Artery Bypass Grafting (CABG)High Risk PatientsCardiopulmonary BypassElective Cardiac SurgeryValvular Heart SurgeryMultiple Valve SurgeriesCombined Cardiac ProceduresAortic Surgical ProceduresAdult Patients ≥ 18 YearsCombined Valve and CABGCombined Cardiac and Aortic Surgical Procedures
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCP-Service International West GmbH

About this trial

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

A total of 550 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent prior to study participation

Adult patients (≥ 18 years)

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%

Disqualifiers

Known hypersensitivity to fish oil/fish products or egg protein

Pregnancy or lactation period

Previous history of chronic atrial fibrillation, atrial flutter and/or atrial tachyarrhythmia

Inability or unwillingness of individual to give written informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fish Oil

    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

  • Intravenous 0.9% Sodium Chloride

    Drug

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

Treatment groups

550 Participants
are divided into 2 treatment groups
Group A: Treatment groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Atrial fibrillation

The primary objective is to demonstrate superiority of fish oil compared to placebo in the prevention of atrial fibrillation until 7 days after surgery. This clinical endpoint is assessed as part of the clinical practice.

Time frame
Postoperative days 0-7

Secondary outcomes

1

Mechanical ventilation

Duration of mechanical ventilation

Time frame
Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up
2

Adverse Events

AEs leading to discontinuation/AEs at least possibly related to the IMP/SAEs

Time frame
Preoperative day -1 to 12 months follow-up
3

Delta Sequential Organ Failure Assessment Score (SOFA) Score

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.

Time frame
Postoperative days 0-7
4

Stroke

Incidence of stroke

Time frame
Postoperative days 0-7

Other outcomes

1

Optional tertiary endpoint: Ultrasound measurement of thigh skeletal muscle mass

Ultrasound measurement of thigh skeletal muscle mass

Time frame
Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)
2

Optional tertiary endpoint: Functional Status Score for Intensive Care Unit (FSS-ICU)

Functional Status Score for Intensive Care Unit (FSS-ICU)

Time frame
Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)
3

Optional tertiary endpoint: Short Physical Performance Battery test (SPPB)

Short Physical Performance Battery test (SPPB)

Time frame
Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)
4

Optional tertiary endpoint: Hand grip/held dynamometer

Hand grip/held dynamometer

Time frame
Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GCP-Service International West GmbH

Lead sponsor

University Hospital, Bonn

Collaborator

University Hospital Muenster

Collaborator

University Hospital Goettingen

Collaborator

University Hospital Schleswig-Holstein

Collaborator

Charite University, Berlin, Germany

Collaborator

Wuerzburg University Hospital

Collaborator

Johannes Gutenberg University Mainz

Collaborator

University Hospital Augsburg

Collaborator

Universitätsklinikum Hamburg-Eppendorf

Collaborator

University Medical Center Rostock

Collaborator

Robert Bosch Medical Center

Collaborator

Source ClinicalTrials.gov
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