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Initiation of Hydrocortisone for the Treatment of Septic Shock

Not Applicable
Completed
Conditions
Septic Shock
Interventions
Registration Number
NCT02580240
Lead Sponsor
Northern Jiangsu People's Hospital
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
118
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlacebosalineVials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
hydrocortisoneHydrocortisoneHydrocortisone 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).
Primary Outcome Measures
NameTimeMethod
28-day Mortality28 days

Death from any cause at 28 days after the onset of septic shock

Secondary Outcome Measures
NameTimeMethod
All Cause Mortality90 days

Death from any cause at 90 days after the onset of septic shock

Trial Locations

Locations (1)

Northern Jiangsu Province people's hospital

🇨🇳

Yangzhou, Jiangsu, China

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