Stress Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock

Phase 3

Completed

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

• Registration Number: NCT02266589
• Lead Sponsor: Nanjing PLA General Hospital

Brief Summary

The purpose of this study is to find out whether stress doses of hydrocortisone attenuate coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by which little doses of hydrocortisone influence coagulation system in sepsis.

Detailed Description

Patients were randomized to receive either low-dose hydrocortisone or matching placebo.Severity of coagulopathy was estimated using ISTH DIC score. We determined the complications and mortality in two groups, and analyzed the relationship between hydrocortisone and coagulopathy.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-10
• Study First Submitted: 2014-10-12
• Study First Submitted QC: 2014-10-16
• Last Update Submitted: 2014-10-16
• Study First Posted: 2014-10-17
• Last Update Posted: 2014-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• All patients(age≧18y)
• Admitted for septic shock were considered eligible if they had no life-threatening systemic disease (ASA groups 1~3)

Exclusion Criteria

• Lactation
• Mental disorders
• Disseminated cancer
• Secondary cancers
• Inflammatory bowel disease, or diseases hindering epidural analgesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrocortisone	Hydrocortisone	little doses of hydrocortisone

Primary Outcome Measures

Name	Time	Method
coagulopathy	30 days after inclusion	ISTH score

Secondary Outcome Measures

Name	Time	Method
clinical complications	30 days after inclusion	MODS SOFA score
death	30 days after inclusion