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

Coagulation Dysfunction in Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02114710
• Other study ID #: 2009NLY078
• Status: Completed
• Phase: Phase 3
• First received: April 12, 2014
• Last updated: April 14, 2014
• Start date: May 2009
• Est. completion date: October 2012

Study information

• Verified date: April 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: 240
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 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

• Coagulation Dysfunction in Septic Shock
• Hemodynamic Improvement Induced by Hydrocortisone
• 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	death		30 days after inclusion	Yes
Secondary	clinical perioperative complications		30 days after inclusion	Yes
Secondary	clinical complications	MODS SOFA score	30 days after inclusion	Yes