Early Initiation of Low-dose Hydrocortisone Treatment for Septic Shock in Adults: a Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- saline
- Conditions
- Septic Shock
- Sponsor
- Northern Jiangsu People's Hospital
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- 28-day Mortality
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Qing-quan Lv
Ms Lv
Northern Jiangsu People's Hospital
Eligibility Criteria
Inclusion Criteria
- •age 18 years old or older;
- •onset of septic shock within 6 h
Exclusion Criteria
- •Systemic corticosteroid therapy within the last 3 months before septic shock;
- •high-dose steroid therapy;
- •immunosuppression;
- •refusal of the attending staff or patient family.
Arms & Interventions
Placebo
Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
Intervention: saline
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: Hydrocortisone
Outcomes
Primary Outcomes
28-day Mortality
Time Frame: 28 days
Death from any cause at 28 days after the onset of septic shock
Secondary Outcomes
- All Cause Mortality(90 days)