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

Nanjing PLA General Hospital

Status and phase: Completed; Phase 3

Conditions: Septic Shock; Sepsis

Treatments: Drug: Hydrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT02266589

2011NLY031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups

Hydrocortisone

Experimental group

Description:

little doses of hydrocortisone

Treatment:

Drug: Hydrocortisone

Placebo

No Intervention group

Description:

Placebo