Clinical trial • Phase III • Cardiology

HYDROCORTISONE for Scheduled cardiac surgery (intermediate/high risk) | Acute renal failure

Phase III trial of HYDROCORTISONE for Scheduled cardiac surgery (intermediate/high risk) | Acute renal failure.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Scheduled cardiac surgery (intermediate/high risk) | Acute renal failure
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
06-01-2025
First CTIS Authorization Date
30-04-2025

Trial design

Randomised, placebo arms: sodium chloride (irrigation solution / infusion) as placebo comparator for hydrocortisone; cellulose, microcrystalline (oral powder) as placebo comparator for fludrocortisone. active treatment: hydrocortisone (solution for injection/infusion; max daily amount recorded 200 mg; treatment period 5 days) + fludrocortisone (tablet; max daily amount recorded 50 µg; treatment period 5 days). exact dosing schedule not specified in ctis data beyond 'prolonged corticosteroid therapy for 5 days'.-controlled Phase III trial across 4 sites in France.

Randomised
Yes
Comparator
Placebo arms: SODIUM CHLORIDE (IRRIGATION SOLUTION / infusion) as placebo comparator for hydrocortisone; CELLULOSE, MICROCRYSTALLINE (ORAL POWDER) as placebo comparator for fludrocortisone. Active treatment: HYDROCORTISONE (solution for injection/infusion; max daily amount recorded 200 mg; treatment period 5 days) + FLUDROCORTISONE (tablet; max daily amount recorded 50 µg; treatment period 5 days). Exact dosing schedule not specified in CTIS data beyond 'prolonged corticosteroid therapy for 5 days'.
Target Sample Size
196
Trial Duration For Participant
28

Eligibility

Recruits 196 Patients under guardianship, curatorship or safeguard of justice are excluded; signed informed consent is required from participants. No vulnerable population selected; no assent process described..

Pregnancy Exclusion
Pregnant or breast-feeding women
Vulnerable Population
Patients under guardianship, curatorship or safeguard of justice are excluded; signed informed consent is required from participants. No vulnerable population selected; no assent process described.

Inclusion criteria

  • {"criterion_text":"- Age > 18 years.\n- Patient at intermediate/high risk (Euroscore II>4%)\n- Patient admitted for scheduled cardiac surgery\n- Extracorporeal circulation\n- signed informed consent"}

Exclusion criteria

  • {"criterion_text":"- Endocarditis\n- End-stage renal failure with long-term dialysis\n- - Contraindications to the administration of hydrocortisone and/or fludrocortisone according to the drugs' prescribing information\n- Pregnant or breast-feeding women\n- Patients under guardianship, curatorship or safeguard of justice\n- Beating heart surgery\n- Heart transplantation or long-term ventricular assistance\n- Emergency surgery: aortic dissection, emergency coronary artery bypass surgery\n- Failed exit from bypass with need for short-acting assistance (counterpulsation balloon, ECMO)\n- Hypothermic surgery\n- Previous cardiac surgery\n- Patient on long-term corticosteroid therapy\n- Autoimmune or chronic inflammatory disease."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Occurrence within 7 days of surgery of any of the following: acute renal failure (ARF), postoperative pulmonary complication (PPC), or use of noradrenaline."}

Secondary endpoints

  • {"endpoint_text":"- Major cardiac events (MCE)\n- Stroke will be defined by the sudden onset of neurological deficit and confirmed by brain imaging.\n- 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.\n- The side-effects of interest are as follows: \tHypernatremia defined by a natraemia > 145 mmol/l. \tHyperglycemia defined by the need for insulin therapy. \tOne of the following infections: urinary tract infection, postoperative pneumonitis, mediastinitis.\n- Mortality at 28 days is defined as death from any cause from the date of surgery up to and including day 28.","definition_or_measurement_approach":"Major cardiac events (MCE): composite (as specified in secondary objectives) including postoperative atrial fibrillation (PAF), cerebrovascular accident (CVA/stroke), myocardial infarction (MI). Stroke: sudden onset of neurological deficit confirmed by brain imaging. Total noradrenaline: expressed in mg from ICU admission until day 7 after surgery. Side-effects: hypernatremia defined by natremia >145 mmol/L; hyperglycaemia defined by need for insulin therapy; specified infections (urinary tract infection, postoperative pneumonitis, mediastinitis). Mortality at 28 days: death from any cause up to and including day 28 after surgery."}

Recruitment

Planned Sample Size
196
Recruitment Window Months
37
Consent Approach
Signed informed consent is required from participants (Age >18). Subject information and informed consent form documents (L1) are provided; materials and translations include French. No assent process described (paediatric subjects excluded).

Geography

Total Number Of Sites
4
Total Number Of Participants
196

France

Earliest CTIS Part Ii Submission Date
14-03-2025
Latest Decision Or Authorization Date
30-04-2025
Processing Time Days
47
Number Of Sites
4
Number Of Participants
196

Sites

Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Intensive care
Principal Investigator Name
Christophe Beyls
Principal Investigator Email
beyls.christophe@chu-amiens.fr
Contact Person Name
Christophe Beyls
Contact Person Email
beyls.christophe@chu-amiens.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Intensive care
Principal Investigator Name
Mouhamed Moussa
Principal Investigator Email
'mouhamed.moussa@chru-lille.fr
Contact Person Name
Mouhamed Moussa
Contact Person Email
'mouhamed.moussa@chru-lille.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Intensive care
Principal Investigator Name
Emmanuel Besnier
Principal Investigator Email
Emmanuel.Besnier@chu-rouen.fr
Contact Person Name
Emmanuel Besnier
Contact Person Email
Emmanuel.Besnier@chu-rouen.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Anesthesie Réanimation
Principal Investigator Name
Ossama Abou Arab
Principal Investigator Email
abouarab.osama@chu-amiens.fr
Contact Person Name
Ossama Abou Arab
Contact Person Email
abouarab.osama@chu-amiens.fr

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire Amiens Picardie
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
HYDROCORTISONE
Active Substance
HYDROCORTISONE
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Maximum Dose
200 mg per day (maxDailyDoseAmount=200 mg); max total amount recorded 1000 mg; max treatment period 5 days
Investigational Product Name
FLUDROCORTISONE
Active Substance
FLUDROCORTISONE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
50 µg per day (maxDailyDoseAmount=50 µg); max total amount recorded 250 µg; max treatment period 5 days
Investigational Product Name
SODIUM CHLORIDE
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Maximum Dose
200 mg per day (as recorded in product data)
Investigational Product Name
CELLULOSE, MICROCRYSTALLINE
Active Substance
CELLULOSE, MICROCRYSTALLINE
Modality
Other
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
50 µg per day (as recorded in product data)
Combination Treatment
Yes

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