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

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ClinicalTrials.gov Identifier: NCT02266589
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : October 17, 2014
Sponsor:
Information provided by (Responsible Party):
Gao Tao, Nanjing PLA General Hospital

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.

Condition or disease Intervention/treatment Phase
Septic Shock Sepsis Drug: Hydrocortisone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Research of Little Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock
Study Start Date : November 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013


Arm Intervention/treatment
Experimental: Hydrocortisone
little doses of hydrocortisone
Drug: Hydrocortisone
Hydrocortisone hemisuccinate (Roussel-Uclaf, Romainville, France), 50 mg intravenously every 6 hrs

No Intervention: Placebo
Placebo



Primary Outcome Measures :
  1. coagulopathy [ Time Frame: 30 days after inclusion ]
    ISTH score


Secondary Outcome Measures :
  1. death [ Time Frame: 30 days after inclusion ]
  2. clinical complications [ Time Frame: 30 days after inclusion ]
    MODS SOFA score



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Gao Tao, Nanjing PLA General Hospital
ClinicalTrials.gov Identifier: NCT02266589     History of Changes
Other Study ID Numbers: 2011NLY031
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: October 17, 2014
Last Verified: October 2014
Keywords provided by Gao Tao, Nanjing PLA General Hospital:
coagulopathy
hydrocortisone
organ failure
hemodynamic improvement induced by hydrocortisone
Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Anti-Inflammatory Agents