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

Nanjing PLA General Hospital240 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

240

Conditions

Coagulation Dysfunction in Septic Shock Hemodynamic Improvement Induced by Hydrocortisone

Interventions

HydrocortisoneDRUG

Hydrocortisone hemisuccinate (Roussel-Uclaf, Romainville, France), 50 mg intravenously every 6 hrs

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

death

Time frame: 30 days after inclusion

Secondary Outcomes

clinical perioperative complications

Time frame: 30 days after inclusion

clinical complications

MODS SOFA score

Time frame: 30 days after inclusion

Data from ClinicalTrials.gov

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