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

Septic Shock Clinical Trial

— HSHC00582434  

Official title:

Double Blinded, Randomized Trial, Comparing Intravenous Bolus of 50 mg of Hydrocortisone Every 6 Hours for 7 Days With a Continuous Infusion of 300 mg Per Day of Hydrocortisone 300-mg Group During 5 Days in the Treatment of Septic Shock.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768740
• Other study ID #: 2007-005824-34
• Status: Completed
• Phase: Phase 4
• First received: May 10, 2016
• Last updated: May 20, 2016
• Start date: April 2008
• Est. completion date: September 2014

Study information

• Verified date: May 2016
• Source: Association Niçoise de Réanimation Médicale
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Description:

Hydrocortisone hemisuccinate (Hydrocortisone Upjohn) was supplied as a powder in 100 mg vials to be reconstituted with 2 ml of sterile water diluent. The placebo was saline serum supplied as 10 ml ampoules. The study drugs were administered according to two protocols. 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. In the two groups, hydrocortisone was stopped abruptly at the end of treatment. The investigators had the choice or resuming hydrocortisone at the end of the fifth day if deemed necessary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2014
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• medical history of adrenal insufficiency

• ongoing corticosteroid treatment

• pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Hydrocortisone hemisuccinate
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Association Niçoise de Réanimation Médicale

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	The primary end point was to determine a difference in 28-day mortality between the 200-mg and 300-mg groups.	28-day	No
Secondary	Incidence of permanent shock between groups	Permanent shock (PS) was defined as permanent catecholamine support (epinephrine or norepinephrine) in the ICU, from the onset of septic shock to death without a period of reversal.	28-day	No
Secondary	Incidence of shock relapse between groups	Shock relapse (SR) was defined as recurrence of septic shock requiring catecholamine resumption.	28-day	No
Secondary	Incidence of post hydrocortisone hemodynamic rebound between groups	Post hydrocortisone hemodynamic rebound (PHHR) was defined as SR within 48 hours after hydrocortisone cessation.	28-day	No
Secondary	Incidence of adverse events between groups.	Incidences of hemorrhagic events, superinfections and the amount of needed insulin were compared between the two groups.	28-day	Yes