Rapid Recognition of Corticosteroid Resistant or Sensitive Sepsis

Summary

Main objective and primary endpoint: To compare the effect hydrocortisone plus fludrocortisone vs. placebo on a composite of death or persistent organ dysfunction - defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors - assessed at 90 days on intensive care unit (ICU) adults and having different biological profiles for immune responses and corticosteroids bioactivity.

Secondary objectives and endpoints:

* Mortality and health-related quality of life at 6 months;
* Daily organ function (SOFA score days 1, 2, 3, 4, 7, 10, 14, 28, and 90);
* Daily secondary infections (up to 90 days)
* Daily blood and urinary levels of glucose, sodium and potassium (up to 28 day)
* Daily gastroduodenal bleeding (up to 28 day)
* Daily cognitive function and muscles' strength (days 1 to 28, 90 and 180 days).

Conditions

• Sepsis

Interventions

DRUG

Administration procedures

Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours; 9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 μg tablet via a nasogastric tube once per day in the morning. Study drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• Versailles Saint-Quentin-en-Yvelines University

  collaborator OTHER

• Université Paris-Saclay

  collaborator OTHER

• Paris 12 Val de Marne University

  collaborator OTHER

• Commissariat A L'energie Atomique

  collaborator OTHER_GOV

• Beckman Coulter, Inc.

  collaborator INDUSTRY

• Lumedix

  collaborator UNKNOWN

• Elice

  collaborator UNKNOWN

• Biothelis

  collaborator UNKNOWN

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Djillali ANNANE, MD, PhD · Department of medical and surgical Intensive Care Unit, - Raymond Poincaré Hospital - APHP

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-10

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• France

Study Locations