Initiation of Hydrocortisone for the Treatment of Septic Shock

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study : 1）to determine whether hydrocortisone is effective in the treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone administration in septic shock patients.

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Detailed Description

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Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.

hydrocortisone

Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).

Group Type EXPERIMENTAL

Hydrocortisone

Intervention Type DRUG

Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).

Interventions

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Hydrocortisone

Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).

Intervention Type DRUG

saline

Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.

Intervention Type DRUG

Other Intervention Names

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cortisol Normal saline

Eligibility Criteria

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Inclusion Criteria

1. age 18 years old or older;
2. onset of septic shock within 6 h

Exclusion Criteria

1. Systemic corticosteroid therapy within the last 3 months before septic shock;
2. high-dose steroid therapy;
3. immunosuppression;
4. refusal of the attending staff or patient family.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No