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

Condition(s) targeted: Coagulation Dysfunction in Septic Shock; Hemodynamic Improvement Induced by Hydrocortisone

Intervention: Hydrocortisone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Nanjing PLA General Hospital

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.

Official title: Study of Little Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: death

Secondary outcome:

clinical perioperative complications

clinical complications

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.

Minimum age: 18 Years. Maximum age: 78 Years. Gender(s): Both.

Criteria:

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

Starting date: May 2009
Last updated: April 14, 2014