Administration of Hydrocortisone for the Treatment of Septic Shock

Septic Shock Clinical Trial

Official title:

Administration of Hydrocortisone for the Treatment of Septic Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02580240
• Other study ID #: 2015KY-127
• Status: Recruiting
• Phase: N/A
• First received: October 18, 2015
• Last updated: October 19, 2015
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2015
• Source: Northern Jiangsu Province People's Hospital
• Contact: Qingquan Lv, Master
• Phone: 0086-18051063899
• Email: bonhomie2014[@]163.com
• Is FDA regulated: No
• Health authority: China: YangZhou Science and Technology Bureau
• Study type: Interventional

Clinical Trial Summary

The purpose of this study : 1）to determine whether hydrocortisone is effective in the treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone administration in septic shock patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age 18 years old or older;

2. onset of septic shock within 6 h and

3. treated with norepinephrine

Exclusion Criteria:

1. Systemic corticosteroid therapy within the last 3 months before septic shock;

2. high-dose steroid therapy;

3. immunosuppression;

4. refusal of the attending staff or patient family.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Hydrocortisone
Hydrocortisone (300 mg/d as a continuous infusion for 6d, then tapered off.) Once all vasopressors were discontinued, the hydrocortisone taper protocol was initiated (HC 50 mg every 8 h for two days, then HC 50 mg every 12 h for two days, then HC 50 mg daily for one day, then stopped)
• saline
Normal saline (300 mg/d as a continuous infusion for 6d, then tapered off.) Once all vasopressors were discontinued, the normal saline taper protocol was initiated (NS 50 mg every 8 h for two days, then NS 50 mg every 12 h for two days, then NS 50 mg daily for one day, then stopped)

Locations

Country	Name	City	State
China	Northern Jiangsu Province people's hospital	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Northern Jiangsu Province People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		within the first 28 days after the onset of septic shock	No
Secondary	all cause mortality		within the first 90 days after the onset of septic shock	No