Intensive Care UnitPhase 2MODIFY CSXNCT06279793
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
A Phase 2 study testing Fish Oil and Intravenous 0.9% Sodium Chloride in people with Intensive Care Unit and Coronary Artery Bypass Grafting (CABG), run by GCP-Service International West GmbH at 10 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit, Coronary Artery Bypass Grafting (CABG), High Risk Patients
- What is being tested?
- Fish Oil and Intravenous 0.9% Sodium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 550 participants
- Where
- 10 sitesGermany
- Study dates
- 15 Feb 2024to Sep 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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)
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- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Germany10 sites, 10 recruiting
- Recruiting
University Hospital Augsburg
Augsburg
Philipp Simon, Prof. Dr., +49 821 400 - 2371, philipp.simon3@uk-augsburg.de
Manfred Weiss, Prof. Dr., Manfred.Weiss@uk-augsburg.de
- Recruiting
Charité Universitätsmedizin Berlin
Berlin
Sascha Ott, M.D, 49-30-4593-2600, sascha.ott@dhzc-charite.de
Maren Kleine-Brüggeney, M.D, maren.kleine-brueggeney@dhzc-charite.de
- Recruiting
University of Bonn
Bonn
Florian Piekarski, M.D, +49 171-3150966, Florian.Piekarski@ukbonn.de
Christian Bode, M.D, Christian.Bode@ukbonn.de
- Recruiting
University Hospital Goettingen
Göttingen
Reiner Wäschle, M.D, 49-551-3967701, Reiner.Waeschle@med.uni-goettingen.de
Anselm Bräuer, M.D., anselm.braeuer@med.uni-goettingen.de
- Recruiting
University Hospital Hamburg-Eppendorf
Hamburg
Bernd Saugel, Prof. Dr., +49 40 7410-52415, b.saugel@uke.de
Ekaterina Nekhaeva, Dr., e.nekhaeva@uke.de
- Recruiting
University Medical Center Schleswig-Holstein
Kiel
Radke David, M.D, 49-431 - 500 20801, David.Radke@uksh.de
Matthias Lindner, M.D, Matthias.Lindner@uksh.de
- Recruiting
University Hospital Mainz
Mainz
Daniel Dürr, Prof. Dr., +49 6131 17-2106, Daniel.Duerr@unimedizin-mainz.de
Jan Beer, Dr., Jan.Beer@unimedizin-mainz.de
- Recruiting
University Hospital Muenster
Münster
Alexander Zarbock, M.D, 49-251-83-44017, zarbock@uni-muenster.de
Hendrik Booke, M.D, Hendrik.Booke@ukmuenster.de
- Not yet recruiting
University Medical Center Rostock
Rostock
Jens-Christian Schewe, M.D., 49-431-500 20801, Jens-Christian.Schewe@med.uni-rostock.de
Benjamin Löser, M.D., 49-381-494 146234, Benjamin.loeser@med.uni-rostock.de
- Recruiting
Robert Bosch Medical Center
Stuttgart
Christian Wunder, M.D., 49-711-8101 3484, christian.wunder@rbk.de
Magdalena Rufa, M.D., 49-711-8101 5069, magdalena.rufa@rbk.de
About this study
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 -
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.
Read the detailed description
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).
- Conditions
- Intensive Care Unit, Coronary Artery Bypass Grafting (CABG), High Risk Patients, Cardiopulmonary Bypass, Elective Cardiac Surgery, Valvular Heart Surgery
- Being tested
- Fish Oil, Intravenous 0.9% Sodium Chloride
- Keywords
- intensive care unit, elective cardiac surgery, fish oil, medical nutrition therapy, atrial fibrillation, atrial flutter, atrial tachycardia
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDrug
Also called Omegaven®
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 ChlorideDrug
Also called Saline Infusion
Intravenous 0.9% Sodium Chloride (volume 2 mL/kg BW/d) provided at the same timepoints as the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients will receive 0.20 g fish oil/kg BW/d (≙2 mL Omegaven®/kg BW/d). Receives: Drug: Fish Oil |
| Control group | Placebo comparator | Patients will receive 0,9% NaCl in volume 2 mL/kg BW/d (placebo). Receives: Drug: Intravenous 0.9% Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative days 0-7
Secondary outcomes (19)
Mechanical ventilation
Duration of mechanical ventilation
Measured: Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up
Adverse Events
AEs leading to discontinuation/AEs at least possibly related to the IMP/SAEs
Measured: Preoperative day -1 to 12 months follow-up
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.
Measured: Postoperative days 0-7
Stroke
Incidence of stroke
Measured: Postoperative days 0-7
Inotropics/vasopressors
Duration of inotropic/vasopressor support
Measured: Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up
Acute Kidney Injury
Kidney Disease: Improving Global Outcomes [KDIGO] stages 1-3
Measured: Postoperative days 0-7
Infection rate
Number of infections
Measured: Postoperative days 0-7
Survival status
Overall survival
Measured: 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
Quality of Life (SF-36)
To measure the quality of life
Measured: Screening (preoperative day -7 until day -1), day 30 follow-up, 3, 6, and 12 months follow-up
Postoperative bleeding
Bleeding after surgery
Measured: Postoperative days 0-7
Time to ICU discharge alive
Number of days alive in the ICU
Measured: ICU discharge (approximately 3-4 days after surgery)
Time to hospital discharge alive
Number of days alive in the hospital
Measured: Hospital discharge (approximately 1-2 weeks after surgery)
Physical activity assessment
Katz activities of daily living (ADL) and Lawton Instrumental ADL (IADL)
Measured: Screening (preoperative day -7 until day -1), day 30 follow-up, 3 and 6 months follow-up
Days alive and out of hospital
Time to be alive and discharge from hospital
Measured: Day 30 follow-up, 3, 6, and 12 months follow-up
Time to discharge alive
Time to be alive and discharged from ICU/hospital
Measured: ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)
Weaning from cardiopulmonary bypass (CPB)
Number of attempts to wean from CPB during surgery
Measured: Intraoperative day 0 (during surgery)
Persistent Organ Dysfunction + Death
Requiring supportive technologies during the convalescent phase of critical illness
Measured: Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up
ICU Readmission rates
Readmission to ICU
Measured: Day 30 follow-up, 3, 6, and 12 months follow-up
Hospital Readmission rates
Readmission to hospital
Measured: Day 30 follow-up, 3, 6, and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start15 Feb 2024
- Primary completionMar 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCP-Service International West GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Bonn, University Hospital Muenster, University Hospital Goettingen, Charite University, Berlin, Germany, Wuerzburg University Hospital, Johannes Gutenberg University Mainz, University Hospital Augsburg, Universitätsklinikum Hamburg-Eppendorf, University Medical Center Rostock, University Hospital Schleswig-Holstein, Robert Bosch-Krankenhaus Stuttgart
- Responsible party
- Sponsor
- Investigators
- Christian Stoppe, Prof. Dr., Study director, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279793
- Sponsor's protocol ID
- MODIFY CSX
- Acronym
- MODIFY CSX
- Status last verified
- Jul 2026
- First submitted
- 13 Sep 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No