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New treatment option for Intensive Care Unit
Official title Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
ClinicalTrials.gov ID: NCT06279793
What this study is testing
What is Fish Oil?
Fish Oil is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for intensive care unit.
Also referred to as Omegaven®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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"...
See the full eligibility 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...
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Augsburg, Germany
- Berlin, Germany
- Bonn, Germany
- Göttingen, Germany
- Hamburg, Germany
- Kiel, Germany
- Mainz, Germany
- Münster, Germany
- Rostock, Germany
- Stuttgart, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Augsburg, Germany; Berlin, Germany; Bonn, Germany; Göttingen, Germany; Hamburg, Germany; Kiel, Germany and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.