NCT02114710

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2009

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

3.4 years

First QC Date

April 12, 2014

Last Update Submit

April 14, 2014

Conditions

Coagulation Dysfunction in Septic ShockHemodynamic Improvement Induced by Hydrocortisone

Keywords

coagulopathyhydrocortisoneorgan failure

Outcome Measures

Primary Outcomes (1)

  • death

    30 days after inclusion

Secondary Outcomes (2)

  • clinical perioperative complications

    30 days after inclusion

  • clinical complications

    30 days after inclusion

Study Arms (2)

Hydrocortisone

EXPERIMENTAL

little doses of hydrocortisone

Drug: Hydrocortisone

Placebo

NO INTERVENTION

Placebo

Interventions

HydrocortisoneDRUG

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

Hydrocortisone

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients(age≧18y)
  • Admitted for septic shock were considered eligible if they had no life-threatening systemic disease (ASA groups 1\~3)

You may not qualify if:

  • Lactation
  • Mental disorders
  • Disseminated cancer
  • Secondary cancers
  • Inflammatory bowel disease, or diseases hindering epidural analgesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemostatic Disorders

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nanjing PLA General Hospital

Study Record Dates

First Submitted

April 12, 2014

First Posted

April 15, 2014

Study Start

May 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

April 15, 2014

Record last verified: 2014-04