Prolonged corticosteroid therapy in scheduled cardiac surgery in intermediate/high-risk patients: a prospective multicenter randomized controlled double-blind placebo-controlled study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Amiens Picardie

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2025-04-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy

demonstrate the efficacy of prolonged corticosteroid therapy for 5 days (Hydrocortisone + Fludrocortisone) versus placebo in intermediate/high-risk patients undergoing scheduled cardiac surgery.

Secondary objectives 4

1. Comparing bewteen both groups : -The occurrence of any of the following major cardiovascular events (MCE) within 7 days of surgery: Occurrence of postoperative atrial fibrillation (PAF). Cerebrovascular accident (CVA). Occurrence of myocardial infarction (MI).
2. comparing between bothe groups the Cumulative norepinephrine levels within 7 days of surgery
3. comparing between both groups the side effects 7 days after surgery
4. comparing between both groups the moratlity at 28 days

Conditions and MedDRA coding

high /medium risk cardiac surgery

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age > 18 years.
2. Patient at intermediate/high risk (Euroscore II>4%)
3. Patient admitted for scheduled cardiac surgery
4. Extracorporeal circulation
5. signed informed consent

Exclusion criteria 13

1. Endocarditis
2. Beating heart surgery
3. Heart transplantation or long-term ventricular assistance
4. Emergency surgery: aortic dissection, emergency coronary artery bypass surgery
5. Failed exit from bypass with need for short-acting assistance (counterpulsation balloon, ECMO)
6. Hypothermic surgery
7. Previous cardiac surgery
8. Patient on long-term corticosteroid therapy
9. Autoimmune or chronic inflammatory disease.
10. End-stage renal failure with long-term dialysis
11. - Contraindications to the administration of hydrocortisone and/or fludrocortisone according to the drugs' prescribing information
12. Pregnant or breast-feeding women
13. Patients under guardianship, curatorship or safeguard of justice

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is a composite of the occurrence within 7 days of surgery of one of the following 3 events: - Acute renal failure (ARF). - Occurrence of a postoperative pulmonary complication (PPC). - Use of noradrenaline.

Secondary endpoints 5

1. Major cardiac events (MCE)
2. Stroke will be defined by the sudden onset of neurological deficit and confirmed by brain imaging.
3. The total quantity of noradrenaline will be expressed in mg and will correspond to the dose received from admission to intensive care until day 7 after surgery.
4. The side-effects of interest are as follows: Hypernatremia defined by a natraemia > 145 mmol/l. Hyperglycemia defined by the need for insulin therapy. One of the following infections: urinary tract infection, postoperative pneumonitis, mediastinitis.
5. Mortality at 28 days is defined as death from any cause from the date of surgery up to and including day 28.

Investigational products

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

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Amiens Picardie

Sponsor organisation

Centre Hospitalier Universitaire Amiens Picardie

Address

1 Rond Point Du Pr Christian Cabrol

City

Amiens Cedex 1

Postcode

80054

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Amiens Picardie

Contact name

Beyls Christophe

Public contact point

Organisation

Centre Hospitalier Universitaire Amiens Picardie

Contact name

Beyls Christophe

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Results and documents

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

Documents 9 files

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

Application history

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