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NCT Number: NCT06279793

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

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.

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Key information

Conditions

Intensive Care Unit Adult Patients ≥ 18 Years Aortic Surgical Procedures Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Cardiopulmonary Bypass Cardiovascular Diseases Combined Cardiac Procedures Combined Cardiac and Aortic Surgical Procedures Combined Valve and CABG Coronary Artery Bypass Grafting (CABG) Elective Cardiac Surgery Heart Diseases High Risk Patients Multiple Valve Surgeries Pathologic Processes Pathological Conditions, Signs and Symptoms Valvular Heart Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Augsburg, Augsburg, Germany

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About this study

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 the onset and occurence of atrial fibrillation after cardiac surgery (AFACS), incorporating atrial fibrillation, atrial flutter, and atrial tachycardia, until day 7 after surgery (on ICU and normal ward).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%

Exclusion criteria

  • 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
  • Not expected to survive an additional 48 hours from screening evaluation
  • Lack of commitment to full, aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated "Do not Resuscitate" [DNR] acceptable)
  • Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma
  • Patients receiving extracorporeal mechanical assist device (e.g. ECLS, or IABP) or advanced heart failure therapies (e.g. TAH, VAD)
  • Enrolment in any other interventional trial will be discussed with the coordinating investigator on a case-by-case scenario and requires sponsor approval before inclusion
  • Already receiving special FO-enriched medical nutrition products
  • Severe malnutrition (as defined by the BMI <18.5)
  • Severe liver dysfunction defined by Child Pugh Class C.
  • Severe chronic kidney dysfunction defined by the National Kidney Foundation (NKF) stage 4 and 5 by using the glomerular filtration rate (GFR <30ml/min)
  • Known severe coagulation disorder

Treatment and study plan

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

Other names: Omegaven®

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.

Other names: Saline Infusion

Primary outcomes

  1. Atrial fibrillation

    Time frame: Postoperative days 0-7

    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.

Secondary outcomes

  1. 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

    Duration of mechanical ventilation

  2. Adverse Events

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

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

  3. Delta Sequential Organ Failure Assessment Score (SOFA) Score

    Time frame: Postoperative 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.

  4. Stroke

    Time frame: Postoperative days 0-7

    Incidence of stroke

  5. Inotropics/vasopressors

    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

    Duration of inotropic/vasopressor support

  6. Acute Kidney Injury

    Time frame: Postoperative days 0-7

    Kidney Disease: Improving Global Outcomes [KDIGO] stages 1-3

  7. Infection rate

    Time frame: Postoperative days 0-7

    Number of infections

  8. Survival status

    Time frame: ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up, months 3, 6, and 12 follow-up

    Overall survival

  9. Quality of Life (SF-36)

    Time frame: Screening (preoperative day -7 until day -1), day 30 follow-up, 3, 6, and 12 months follow-up

    To measure the quality of life

  10. Postoperative bleeding

    Time frame: Postoperative days 0-7

    Bleeding after surgery

  11. Time to ICU discharge alive

    Time frame: ICU discharge (approximately 3-4 days after surgery)

    Number of days alive in the ICU

  12. Time to hospital discharge alive

    Time frame: Hospital discharge (approximately 1-2 weeks after surgery)

    Number of days alive in the hospital

  13. Physical activity assessment

    Time frame: Screening (preoperative day -7 until day -1), day 30 follow-up, 3 and 6 months follow-up

    Katz activities of daily living (ADL) and Lawton Instrumental ADL (IADL)

  14. Days alive and out of hospital

    Time frame: Day 30 follow-up, 3, 6, and 12 months follow-up

    Time to be alive and discharge from hospital

  15. Time to discharge alive

    Time frame: ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)

    Time to be alive and discharged from ICU/hospital

  16. Weaning from cardiopulmonary bypass (CPB)

    Time frame: Intraoperative day 0 (during surgery)

    Number of attempts to wean from CPB during surgery

  17. Persistent Organ Dysfunction + Death

    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

    Requiring supportive technologies during the convalescent phase of critical illness

  18. ICU Readmission rates

    Time frame: Day 30 follow-up, 3, 6, and 12 months follow-up

    Readmission to ICU

  19. Hospital Readmission rates

    Time frame: Day 30 follow-up, 3, 6, and 12 months follow-up

    Readmission to hospital

Other outcomes

  1. Optional tertiary endpoint: 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)

    Ultrasound measurement of thigh skeletal muscle mass

  2. Optional tertiary endpoint: 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)

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

  3. Optional tertiary endpoint: 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)

    Short Physical Performance Battery test (SPPB)

  4. Optional tertiary endpoint: 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)

    Hand grip/held dynamometer

  5. Optional tertiary endpoint: Inflammatory response

    Time frame: Intraoperative day 0, postoperative days 0-7

    Inflammatory response and immune function (measured by markers of the clinical routine (e.g. interleukin [IL-] -6, IL-1β, IL-2, IL-15, interferon [IFN] -γ, monocyte chemotactic protein [MCP] -1, Ferritin, D-Dimer , IL-10, C-reactive protein [CRP], white blood cell count [WBC], procalcitonin [PCT], tumor necrosis factor-α [TNF-α]).

  6. Optional tertiary endpoint: Left ventricular ejection fraction

    Time frame: Preoperative day -1, hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up, 3 and 6 months follow-up

    Left ventricular ejection fractLeft ventricular ejection fractionion

  7. Optional tertiary endpoint: Manual Muscle Testing (MMT)

    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)

    Manual Muscle Testing (MMT)

  8. Optional tertiary endpoint: Vasoactive-Inotropic Score (VIS)

    Time frame: Postoperative days 0-7

    Vasoactive-Inotropic Score (VIS)

  9. Optional tertiary endpoint: Therapeutic Intervention Scoring System (TISS)

    Time frame: Postoperative days 0-7

    A method for measuring workload and calculating costs in the ICU

  10. Optional tertiary endpoint: Development of delirium

    Time frame: Postoperative days 0-7

    Assessed by the CAM ICU score

  11. Optional tertiary endpoint: Hemodynamic parameters

    Time frame: Intraoperative day 0, postoperative days 0-7

    Adequate hemodynamic support, as defined by stable Cardiac Index, cardiac output (CO), Cardiac Power Index, mean arterial pressure (MAP), central vein pressure (CVP), pulmonary artery diastolic pressure (to be measured every 8 hours for first 72 hours post-op or until removal of pulmonary artery catheter, whatever comes first

  12. Optional tertiary endpoint: Clinical frailty scale

    Time frame: Screening (preoperative day -1 until day -7), day 30 follow-up, 3 months follow-up

    A 9-point scale that quantifies frailty based on function in individual patients

  13. Optional tertiary endpoint: Simplified Acute Physiology Score (SAPS)

    Time frame: Postoperative days 0-7

    Estimates the probability of mortality for ICU patients on admission

  14. Optional tertiary endpoints: Further routine biomarkers

    Time frame: Intraoperative day 0, postoperative days 0-7

    Further routine biomarkers: creatinine, urea, bilirubin, troponin, triglycerides if available

  15. Separate Sub-study

    Time frame: Preoperative day -1, intraoperative day 0, postoperative days 0-7, hospital discharge (approximately 1-2 weeks after surgery)

    Serial blood samples and - if available - tissue samples from patients (if these result from the routine surgical procedure) will be collected in concerning patients at the day before (only blood samples), during surgery (only tissue sample if available), and once daily after surgery while the patients are on ICU (only blood samples):

    • Specialized pro-resolving mediators (SPMs) and more specific markers of the inflammatory response, such as the production of leukotriene B5 (LTB5), leukotriene B4 (LTB4), 5-hydroxyeicosapentaenoic acid (5-HEPE) and production of 5-hydroxyeicosatetraenoic acid (5-HETE)
    • SPMs, such as maserins and resolvins
    • Oxidative stress (oxidative reduction potential, Malondialdehyde)
    • Membrane incorporation of PUFAs (white blood cells) &amp;amp;amp;amp; tissue samples
    • Activation of survival kinases (such as extracellular-signal regulated

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Stoppe, Prof. Dr.

CONTACT

[email protected]

49-931-20130001

Ellen Dresen, Dr.

CONTACT

[email protected]

+49 931-201 30392

Sponsors and collaborators

Lead sponsor

GCP-Service International West GmbH

Industry

Collaborators

  • Charite University, Berlin, Germany
  • Johannes Gutenberg University Mainz
  • Robert Bosch-Krankenhaus Stuttgart
  • University Hospital Augsburg
  • University Hospital Goettingen
  • University Hospital Muenster
  • University Hospital Schleswig-Holstein
  • University Hospital, Bonn
  • University Medical Center Rostock
  • Universitätsklinikum Hamburg-Eppendorf
  • Wuerzburg University Hospital

Registry information

Official study title

Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients: a Phase II Multicenter Trial - A Randomized, Placebo-controlled Trial -

Acronym: MODIFY CSX

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Feb 28, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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