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Initiation of Hydrocortisone for the Treatment of Septic Shock

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ClinicalTrials.gov Identifier: NCT02580240
Recruitment Status : Completed
First Posted : October 20, 2015
Results First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Qing-quan Lv, Northern Jiangsu Province People's Hospital

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.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Hydrocortisone Drug: saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Initiation of Low-dose Hydrocortisone Treatment for Septic Shock in Adults: a Randomized Clinical Trial
Study Start Date : September 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Placebo Comparator: Placebo
Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
Drug: saline
Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
Other Name: Normal saline

Experimental: hydrocortisone
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).
Drug: Hydrocortisone
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).
Other Name: cortisol




Primary Outcome Measures :
  1. 28-day Mortality [ Time Frame: 28 days ]
    Death from any cause at 28 days after the onset of septic shock


Secondary Outcome Measures :
  1. All Cause Mortality [ Time Frame: 90 days ]
    Death from any cause at 90 days after the onset of septic shock



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 18 years old or older;
  2. onset of septic shock within 6 h

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580240


Locations
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China, Jiangsu
Northern Jiangsu Province people's hospital
Yangzhou, Jiangsu, China, 225000
Sponsors and Collaborators
Northern Jiangsu Province People's Hospital
Investigators
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Principal Investigator: Qingquan Lv, Master Department of Critical Care Medicine, Northern Jiangsu Province people's hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Qing-quan Lv, Ms Lv, Northern Jiangsu Province People's Hospital
ClinicalTrials.gov Identifier: NCT02580240    
Other Study ID Numbers: 2015KY-127
First Posted: October 20, 2015    Key Record Dates
Results First Posted: August 7, 2017
Last Update Posted: August 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Qing-quan Lv, Northern Jiangsu Province People's Hospital:
septic shock
hydrocortisone
mortality
Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Anti-Inflammatory Agents