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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266589
• Other study ID #: 2011NLY031
• Status: Completed
• Phase: Phase 3
• First received: October 12, 2014
• Last updated: October 16, 2014
• Start date: November 2011
• Est. completion date: October 2013

Study information

• Verified date: October 2014
• Source: Nanjing PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock
• Shock, Septic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing PLA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	coagulopathy	ISTH score	30 days after inclusion	Yes
Secondary	death		30 days after inclusion	Yes
Secondary	clinical complications	MODS SOFA score	30 days after inclusion	Yes