Intravenous Fish Oil based Lipid Emulsion to enhance recovery in High-Risk Cardiac Surgery Patients: a phase II multicenter trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gcp-Service International West GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

15 Nov 2023 → ongoing

Decision date (initial)

2023-08-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Fresenius Kabi Deutschland GmbH

External identifiers

EU CT number

2023-503490-38-00

ClinicalTrials.gov

NCT06279793

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary objective is to demonstrate superiority of fish oil (FO) 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.

Secondary objectives 1

1. Secondary objective is to investigate the effect of FO on recovery after cardiac surgery compared to placebo.

Conditions and MedDRA coding

critical illness, intensive care unit (ICU), surgery

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 1. Written informed consent prior to study participation
2. 2. Adult patients (≥ 18 years)
3. 3. Patients scheduled to undergo elective cardiac surgery with the use of cardiopulmonary bypass (CPB), who are defined as high risk based on having (i) one of the following surgical procedures: -valvular heart surgery only, -coronary artery bypass graft (CABG), -combined valve and CABG, -multiple valve surgeries, -combined cardiac surgical procedures, -aortic surgical procedures (aortic arch and/or descending aorta; aortic valve+ascending aorta), -combined cardiac and aortic surgical procedures (ii) and at least one of the following additional risk factors: a) a high perioperative risk profile, defined as predicted operative mortality of ≥ 8% (European System for Cardiac Operative Risk Evaluation, EuroSCORE II). b) Age ≥70 c) 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 14

1. 1. Known hypersensitivity to FO / fish products or egg protein
2. 10. Already receiving special FO-enriched medical nutrition products
3. 11. Severe malnutrition (as defined by the body mass index [BMI] <18.5)
4. 2. Pregnancy or lactation period
5. 3. Previous history of chronic atrial fibrillation, atrial flutter and/or atrial tachyarrhythmia
6. 4. Inability or unwillingness of individual to give written informed consent
7. 5. Not expected to survive an additional 48 hours from screening evaluation
8. 6. Lack of commitment to full, aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated “Do not Resuscitate” (DNR) acceptable)
9. 7. Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma
10. 8. Patients receiving extracorporeal mechanical assist device (e.g. extracorporeal life support systems [ECLS], intra-aortic balloon pump [IABP]) or advanced heart failure therapies (e.g. total artificial heart [TAH], ventricular assist devices [VAD])
11. 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
12. 12. Severe liver dysfunction defined by Child Pugh Class C.
13. 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)1
14. 14. Known severe coagulation disorder

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. AFACS, incorporating atrial fibrillation, atrial flutter and atrial tachycardia, until 7 days after surgery

Secondary endpoints 17

1. Time to hospital discharge alive (TDA)
2. Days alive and out of hospital within 30 days
3. Number of attempts to wean from CPB during surgery
4. Persistent Organ Dysfunction (POD) + Death within 30 days
5. Time to ICU discharge alive
6. ICU and Hospital Readmission rates
7. Delta Sequential Organ Failure Assessment (SOFA) Score
8. Duration of mechanical ventilation (invasive and non-invasive)
9. Incidence of stroke
10. Duration of inotropic/vasopressor/mechanical support
11. Acute Kidney Injury (by Kidney Disease: Improving Global Outcomes [KDIGO] stages 1-3)
12. Number of infections
13. Overall survival
14. Physical activity (Katz activities of daily living (ADL) and Lawton Instrumental ADL (IADL)
15. Quality of Life (Short Form-36 [SF-36])
16. Postoperative bleeding
17. Adverse events (AEs) leading to discontinuation/AEs at least possibly related to the IMP/Serious adverse events (SAEs)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gcp-Service International West GmbH

Sponsor organisation

Gcp-Service International West GmbH

Address

Siegfeldstrasse 11

City

Siegburg

Postcode

53721

Country

Germany

Scientific contact point

Organisation

Gcp-Service International West GmbH

Contact name

sponsor representative

Public contact point

Organisation

Gcp-Service International West GmbH

Contact name

sponsor representative

Third parties 1

Locations

1 EU/EEA country · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications