Initiation of Hydrocortisone for the Treatment of Septic Shock

Not Applicable

Completed

• Conditions: Septic Shock
• Interventions: Drug: saline; Drug: Hydrocortisone

• 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

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-18
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-20
• Primary Completion: 2016-09
• Study Completion: 2016-12
• Results First Submitted: 2017-01-24
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-30
• Last Update Submitted: 2017-04-30
• Results First Posted: 2017-08-07
• Last Update Posted: 2017-08-07

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

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

Primary Outcome Measures

Name	Time	Method
28-day Mortality	28 days	Death from any cause at 28 days after the onset of septic shock

Secondary Outcome Measures

Name	Time	Method
All Cause Mortality	90 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