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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 after cardiac surgery (AFACS), incorporating atrial fibrillation, atrial flutter and atrial tachycardia, 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

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

University Hospital Schleswig-Holstein

Collaborator

Robert Bosch-Krankenhaus Stuttgart

Collaborator

Source ClinicalTrials.gov
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