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

Launched by GCP-SERVICE INTERNATIONAL WEST GMBH · Feb 19, 2024

Keywords

ClinConnect Summary

The MODIFY CSX study is a clinical trial designed to see if giving high-risk cardiac surgery patients a special fish oil-based nutrient can help them recover better after surgery. The study will enroll 120 patients who are having serious heart operations, like valve surgeries, and are considered at higher risk for complications. Eligible participants must be adults aged 18 or older who can provide consent, and who are scheduled for elective surgeries that involve a heart-lung machine. Some of the key factors that qualify someone as high-risk include being over 70 years old, having a high chance of complications during surgery, or needing urgent procedures.

Patients in the trial will be divided into two groups: one group will receive the fish oil supplement along with their regular care, while the other group will receive a placebo (a dummy treatment) with the same standard care. The trial is currently recruiting participants, and those who join can expect close monitoring during their hospital stay. It's important for potential participants to know that they cannot have certain health conditions, like severe allergic reactions to fish or serious heart issues, to be eligible for this study. Overall, the trial aims to find out if this fish oil treatment can improve recovery outcomes for patients undergoing complex heart surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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%
• Exclusion Criteria:
• • 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 anyinterventional trial within the last 30 days
• • 10. Already receiving FO-containing 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