Back to resultsInitiation of Hydrocortisone for the Treatment of Septic Shock
Primary Purpose
Septic Shock
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hydrocortisone
saline
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring septic shock, hydrocortisone, mortality
Eligibility Criteria
Inclusion Criteria:
- age 18 years old or older;
- onset of septic shock within 6 h
Exclusion Criteria:
- Systemic corticosteroid therapy within the last 3 months before septic shock;
- high-dose steroid therapy;
- immunosuppression;
- refusal of the attending staff or patient family.
Sites / Locations
- Northern Jiangsu Province people's hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
hydrocortisone
Arm Description
Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
Outcomes
Primary Outcome Measures
28-day Mortality
Death from any cause at 28 days after the onset of septic shock
Secondary Outcome Measures
All Cause Mortality
Death from any cause at 90 days after the onset of septic shock
Full Information
NCT ID
NCT02580240
First Posted
October 18, 2015
Last Updated
April 30, 2017
Sponsor
Northern Jiangsu Province People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02580240
Brief Title
Initiation of Hydrocortisone for the Treatment of Septic Shock
Official Title
Early Initiation of Low-dose Hydrocortisone Treatment for Septic Shock in Adults: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern Jiangsu Province People's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
septic shock, hydrocortisone, mortality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
Arm Title
hydrocortisone
Arm Type
Experimental
Arm Description
Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Other Intervention Name(s)
cortisol
Intervention Description
Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
Intervention Type
Drug
Intervention Name(s)
saline
Other Intervention Name(s)
Normal saline
Intervention Description
Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
Primary Outcome Measure Information:
Title
28-day Mortality
Description
Death from any cause at 28 days after the onset of septic shock
Time Frame
28 days
Secondary Outcome Measure Information:
Title
All Cause Mortality
Description
Death from any cause at 90 days after the onset of septic shock
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18 years old or older;
onset of septic shock within 6 h
Exclusion Criteria:
Systemic corticosteroid therapy within the last 3 months before septic shock;
high-dose steroid therapy;
immunosuppression;
refusal of the attending staff or patient family.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingquan Lv, Master
Organizational Affiliation
Department of Critical Care Medicine, Northern Jiangsu Province people's hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Jiangsu Province people's hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28615145
Citation
Lv QQ, Gu XH, Chen QH, Yu JQ, Zheng RQ. Early initiation of low-dose hydrocortisone treatment for septic shock in adults: A randomized clinical trial. Am J Emerg Med. 2017 Dec;35(12):1810-1814. doi: 10.1016/j.ajem.2017.06.004. Epub 2017 Jun 5.
Results Reference
derived
Learn more about this trial
Initiation of Hydrocortisone for the Treatment of Septic Shock
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