Hydrocortisone 50 mg Every 6 Hours Compared to Hydrocortisone 300 mg Per Day in Treatment of Septic Shock.

NCT02768740 | Completed Phase 4

• 1 other identifier: 2007-005824-34
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

We performed a multicenter, prospective, randomized, double-blind, pilot study in four adult medical intensive care units. Patients presenting septic shock were rapidly administered one of two regimens of hydrocortisone, either a 50-mg intravenous bolus every six hours during seven days (200-mg group) or a 100-mg initial bolus followed by a continuous infusion of 300 mg daily for five days (300-mg group). Hydrocortisone was stopped abruptly at the end of treatment.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Mortality

  The primary end point was to determine a difference in 28-day mortality between the 200-mg and 300-mg groups.

  28-day

Secondary Outcomes (4)

• Incidence of permanent shock between groups

  28-day

• Incidence of shock relapse between groups

  28-day

• Incidence of post hydrocortisone hemodynamic rebound between groups

  28-day

• Incidence of adverse events between groups.

  28-day

Study Arms (2)

200 mg group

ACTIVE COMPARATOR

Patients received an intravenous bolus of 50 mg of hydrocortisone every six hours for seven days associated with a continuous infusion of placebo for five days.

Drug: Hydrocortisone hemisuccinate

300 mg group

EXPERIMENTAL

Patients received an initial bolus of 100 mg of hydrocortisone followed by a continuous infusion of 300 mg per day for five days associated with a bolus of placebo every six hours for seven days.

Drug: Hydrocortisone hemisuccinate

Interventions

Hydrocortisone hemisuccinate DRUG

In the 200-mg group, patients received an intravenous bolus of 50 mg of hydrocortisone every six hours for seven days associated with a continuous infusion of placebo for five days. In the 300-mg group, patients received an initial bolus of 100 mg of hydrocortisone followed by a continuous infusion of 300 mg per day for five days associated with a bolus of placebo every six hours for seven days.

Also known as: Saline solution as placebo

200 mg group; 300 mg group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients over 18 years old
• septic shock in accordance with the American College of Chest Physicians/Society of Critical Care Medicine Consensus Committee criteria. Septic shock was managed in accordance with the 2004 edition of the Surviving Sepsis Campaign guidelines.
• no minimal vasopressor dose was needed to enter the trial.

You may not qualify if:

• medical history of adrenal insufficiency
• ongoing corticosteroid treatment
• pregnancy

Sponsors & Collaborators

• Association Niçoise de Réanimation Médicale: lead

MeSH Terms

Conditions

Shock, Septic

Interventions

hydrocortisone hemisuccinate; Saline Solution

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Gilles Bernardin, M.D.

  Association Niçoise de Réanimation Médicale

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 11, 2016
• Study Start: April 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: September 1, 2014
• Last Updated: May 23, 2016

Record last verified: 2016-05