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Clinical Trials/NCT02266589
NCT02266589
Completed
Phase 3

Research of Little Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock

Nanjing PLA General Hospital0 sites84 target enrollmentNovember 2011
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ConditionsSeptic ShockSepsis
InterventionsHydrocortisone
DrugsHydrocortisone

Overview

Phase
Phase 3
Intervention
Hydrocortisone
Conditions
Septic Shock
Sponsor
Nanjing PLA General Hospital
Enrollment
84
Primary Endpoint
coagulopathy
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
October 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nanjing PLA General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Gao Tao

Nanjing PLA General Hospital

Nanjing PLA General Hospital

Eligibility 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

Arms & Interventions

Hydrocortisone

little doses of hydrocortisone

Intervention: Hydrocortisone

Outcomes

Primary Outcomes

coagulopathy

Time Frame: 30 days after inclusion

ISTH score

Secondary Outcomes

  • clinical complications(30 days after inclusion)
  • death(30 days after inclusion)

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