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

Primary Purpose

Septic Shock, Sepsis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Hydrocortisone
Sponsored by
Nanjing PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring coagulopathy, hydrocortisone, organ failure, hemodynamic improvement induced by hydrocortisone

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Hydrocortisone

    Placebo

    Arm Description

    little doses of hydrocortisone

    Placebo

    Outcomes

    Primary Outcome Measures

    coagulopathy
    ISTH score

    Secondary Outcome Measures

    death
    clinical complications
    MODS SOFA score

    Full Information

    First Posted
    October 12, 2014
    Last Updated
    October 16, 2014
    Sponsor
    Nanjing PLA General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02266589
    Brief Title
    Stress Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock
    Official Title
    Research of Little Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    October 2013 (Actual)
    Study Completion Date
    October 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nanjing PLA General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Septic Shock, Sepsis
    Keywords
    coagulopathy, hydrocortisone, organ failure, hemodynamic improvement induced by hydrocortisone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    84 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hydrocortisone
    Arm Type
    Experimental
    Arm Description
    little doses of hydrocortisone
    Arm Title
    Placebo
    Arm Type
    No Intervention
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Hydrocortisone
    Intervention Description
    Hydrocortisone hemisuccinate (Roussel-Uclaf, Romainville, France), 50 mg intravenously every 6 hrs
    Primary Outcome Measure Information:
    Title
    coagulopathy
    Description
    ISTH score
    Time Frame
    30 days after inclusion
    Secondary Outcome Measure Information:
    Title
    death
    Time Frame
    30 days after inclusion
    Title
    clinical complications
    Description
    MODS SOFA score
    Time Frame
    30 days after inclusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

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

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