NCT02114710CompletedPhase 3
Study of Little Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock
Nanjing PLA General Hospital0 sites240 target enrollmentStarted: May 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 240
- Primary Endpoint
- death
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 78 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Hydrocortisone
Experimental
little doses of hydrocortisone
Intervention: Hydrocortisone (Drug)
Outcomes
Primary Outcomes
death
Time Frame: 30 days after inclusion
Secondary Outcomes
- clinical perioperative complications(30 days after inclusion)
- clinical complications(30 days after inclusion)
Investigators
Gao Tao
Nanjing PLA General Hospital
Nanjing PLA General Hospital
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