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Hydrocortisone 50 mg Every 6 Hours Compared to Hydrocortisone 300 mg Per Day in Treatment of Septic Shock. (HSHC00582434)

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ClinicalTrials.gov Identifier: NCT02768740
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Association Niçoise de Réanimation Médicale

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.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Hydrocortisone hemisuccinate Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : April 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : September 2014


Arm Intervention/treatment
Active Comparator: 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.
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.
Other Name: Saline solution as placebo

Experimental: 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.
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.
Other Name: Saline solution as placebo




Primary Outcome Measures :
  1. Mortality [ Time Frame: 28-day ]
    The primary end point was to determine a difference in 28-day mortality between the 200-mg and 300-mg groups.


Secondary Outcome Measures :
  1. Incidence of permanent shock between groups [ Time Frame: 28-day ]
    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.

  2. Incidence of shock relapse between groups [ Time Frame: 28-day ]
    Shock relapse (SR) was defined as recurrence of septic shock requiring catecholamine resumption.

  3. Incidence of post hydrocortisone hemodynamic rebound between groups [ Time Frame: 28-day ]
    Post hydrocortisone hemodynamic rebound (PHHR) was defined as SR within 48 hours after hydrocortisone cessation.

  4. Incidence of adverse events between groups. [ Time Frame: 28-day ]
    Incidences of hemorrhagic events, superinfections and the amount of needed insulin were compared between the two groups.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02768740


Sponsors and Collaborators
Association Niçoise de Réanimation Médicale
Investigators
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Principal Investigator: Gilles Bernardin, M.D. Association Niçoise de Réanimation Médicale

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Responsible Party: Association Niçoise de Réanimation Médicale
ClinicalTrials.gov Identifier: NCT02768740     History of Changes
Other Study ID Numbers: 2007-005824-34
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The data are available for additional analysis
Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Anti-Inflammatory Agents