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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02114710
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : April 15, 2014
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
Coagulation Dysfunction in Septic Shock Hemodynamic Improvement Induced by Hydrocortisone 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 : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Little Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock
Study Start Date : May 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

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

Primary Outcome Measures :
  1. death [ Time Frame: 30 days after inclusion ]

Secondary Outcome Measures :
  1. clinical perioperative complications [ 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 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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

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Responsible Party: Gao Tao, Nanjing PLA General Hospital Identifier: NCT02114710     History of Changes
Other Study ID Numbers: 2009NLY078
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014
Keywords provided by Gao Tao, Nanjing PLA General Hospital:
organ failure
Additional relevant MeSH terms:
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Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Shock, Septic
Pathologic Processes
Systemic Inflammatory Response Syndrome
Anti-Inflammatory Agents