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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02266589
Enrollment
84
Registered
2014-10-17
Start date
2011-11-30
Completion date
2013-10-31
Last updated
2014-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Septic Shock

Keywords

coagulopathy, hydrocortisone, organ failure, hemodynamic improvement induced by hydrocortisone

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.

Interventions

DRUGHydrocortisone

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

Sponsors

Nanjing PLA General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
coagulopathy30 days after inclusionISTH score

Secondary

MeasureTime frameDescription
death30 days after inclusion
clinical complications30 days after inclusionMODS SOFA score

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026