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

NCT06279793
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
550
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Lead sponsor
GCP-Service International West GmbH
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Start date
2024-02-15
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Number of sites
10
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Summary
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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Acronym
MODIFY CSX
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Short title
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
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Official 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 -
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2030-09-01
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First posted
2024-02-28
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Registry last updated
2026-07-08
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Primary completion date
2030-03-01
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Start date
2024-02-15
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Participants
550
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Participant count basis
Estimated
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Planned participants
550
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Protocol amendments
4
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Number of sites
10
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
GCP-Service International West GmbH
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06279793
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ClinicalTrials.gov ID
NCT06279793
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Triple masking
Masking description
Patients as well as clinical staff and outcome assessors not involved in the study will be blinded to study intervention allocation.
Masked roles
Participants, Care providers, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Atrial fibrillation

    Timeframe: 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.

  1. Mechanical ventilation

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: Postoperative days 0-7

    Incidence of stroke

  5. Inotropics/vasopressors

    Timeframe: 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

    Timeframe: Postoperative days 0-7

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

  7. Infection rate

    Timeframe: Postoperative days 0-7

    Number of infections

  8. Survival status

    Timeframe: 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)

    Timeframe: 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

    Timeframe: Postoperative days 0-7

    Bleeding after surgery

  11. Time to ICU discharge alive

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

    Number of days alive in the ICU

  12. Time to hospital discharge alive

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

    Number of days alive in the hospital

  13. Physical activity assessment

    Timeframe: 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

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

    Time to be alive and discharge from hospital

  15. Time to discharge alive

    Timeframe: 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)

    Timeframe: Intraoperative day 0 (during surgery)

    Number of attempts to wean from CPB during surgery

  17. Persistent Organ Dysfunction + Death

    Timeframe: 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

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

    Readmission to ICU

  19. Hospital Readmission rates

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

    Readmission to hospital

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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%

  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 any other interventional trial will be discussed with the coordinating investigator on a case-by-case scenario and requires sponsor approval before inclusion
  10. Already receiving special FO-enriched 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
Sources for eligibility
clinicaltrials.gov

  • University Hospital AugsburgAugsburg, GermanyRecruiting
  • Charité Universitätsmedizin BerlinBerlin, GermanyRecruiting
  • University of BonnBonn, GermanyRecruiting
  • University Hospital GoettingenGöttingen, GermanyRecruiting
  • University Hospital Hamburg-EppendorfHamburg, GermanyRecruiting
  • University Medical Center Schleswig-HolsteinKiel, GermanyRecruiting
  • University Hospital MainzMainz, GermanyRecruiting
  • University Hospital MuensterMünster, GermanyRecruiting
  • University Medical Center RostockRostock, GermanyNot yet recruiting
  • Robert Bosch Medical CenterStuttgart, GermanyRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (11)

Lead sponsors (1)

Conditions (2)