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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517699-39-00
Acronym
PI2024_843_0047
Enrollment
196
Registered
2025-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high /medium risk cardiac surgery, acute renal failure

Brief summary

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.

Detailed description

Major cardiac events (MCE), Stroke will be defined by the sudden onset of neurological deficit and confirmed by brain imaging., 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., 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., Mortality at 28 days is defined as death from any cause from the date of surgery up to and including day 28.

Interventions

DRUGHYDROCORTISONE
DRUGFLUDROCORTISONE
DRUGSODIUM CHLORIDE
DRUGCELLULOSE

Sponsors

Centre Hospitalier Universitaire Amiens Picardie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Major cardiac events (MCE), Stroke will be defined by the sudden onset of neurological deficit and confirmed by brain imaging., 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., 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., Mortality at 28 days is defined as death from any cause from the date of surgery up to and including day 28.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026