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

GCP-Service

Status and phase: Enrolling; Phase 2

Conditions: Cardiac Surgery; Valve Surgeries; Cardiopulmonary Bypass; Intensive Care Unit; High Risk Patients

Treatments: Drug: Intravenous 0.9% Sodium Chloride; Drug: Long-chain n-3 fatty acids

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06279793

MODIFY CSX

Details and patient eligibility

About

The MODIFY CSX study is a randomized, double-blind, controlled trial conducted in heart centers in Germany.

In this prospective randomized controlled blinded multicenter trial, a total of 120 high-risk cardiac surgery patients will receive either fish oil at 0.20 g/kg body weight (BW) + standard of care versus placebo + standard of care.

Full description

The proposed hypothesis is that the therapeutic strategy tested in this randomized trial will decrease the occurrence of postoperative atrial fibrillation, which ultimately lead 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 fish oil in dose 0.20 g/kg body weight (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, month 3, 6, and 12 months.

Primary endpoint (Phase II study):

The primary endpoint for this phase II clinical trial is be the presence of new-onset atrial fibrillation after cardiac surgery (AFACS) until day 7 after surgery.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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) combined valve/CABG or multiple valve surgeries, or combined cardiac/aortic surgical procedures 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 (FO)/ fish products or egg protein

2. Pregnancy or lactation period

3. Previous history of 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

    • lt;30ml/min)

14. Known severe coagulation disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

Patients will receive 0.20 g fish oil/kg BW/d (≙2 mL Omegaven®/kg BW/d).

Treatment:

Drug: Long-chain n-3 fatty acids

Control group

Placebo Comparator group

Description:

Patients will receive 0,9% NaCl in volume 2 mL/kg BW/d (placebo).

Treatment:

Drug: Intravenous 0.9% Sodium Chloride