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

NCT ID: NCT02114710

Last Updated: 2014-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coagulation Dysfunction in Septic Shock Hemodynamic Improvement Induced by Hydrocortisone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hydrocortisone

little doses of hydrocortisone

Group Type EXPERIMENTAL

Hydrocortisone

Intervention Type DRUG

Hydrocortisone hemisuccinate (Roussel-Uclaf, Romainville, France), 50 mg intravenously every 6 hrs

Placebo

Placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hydrocortisone

Hydrocortisone hemisuccinate (Roussel-Uclaf, Romainville, France), 50 mg intravenously every 6 hrs

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients(ageā‰§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
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gao Tao

Nanjing PLA General Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2009NLY078

Identifier Type: -

Identifier Source: org_study_id

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