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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Septic Shock
Interventions Drug: Hydrocortisone
Drug: saline
Enrollment 118
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Hydrocortisone
Hide Arm/Group 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).
Period Title: Overall Study
Started 62 58
Completed 60 58
Not Completed 2 0
Reason Not Completed
Physician Decision             2             0
Arm/Group Title Placebo Hydrocortisone Total
Hide Arm/Group 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). Total of all reporting groups
Overall Number of Baseline Participants 60 58 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 58 participants 118 participants
64.8  (16.7) 68.8  (12.6) 66.77  (14.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 58 participants 118 participants
Female
23
  38.3%
25
  43.1%
48
  40.7%
Male
37
  61.7%
33
  56.9%
70
  59.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 60 participants 58 participants 118 participants
60 58 118
1.Primary Outcome
Title 28-day Mortality
Hide Description Death from any cause at 28 days after the onset of septic shock
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Hydrocortisone
Hide Arm/Group Description:

Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.

saline: 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).

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).

Overall Number of Participants Analyzed 60 58
Measure Type: Count of Participants
Unit of Measure: Participants
19
  31.7%
23
  39.7%
2.Secondary Outcome
Title All Cause Mortality
Hide Description Death from any cause at 90 days after the onset of septic shock
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Hydrocortisone
Hide Arm/Group Description:

Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.

saline: 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).

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).

Overall Number of Participants Analyzed 60 58
Measure Type: Count of Participants
Unit of Measure: Participants
19
  31.7%
23
  39.7%
Time Frame Adverse Events were classified by onset time (within 60 days after the onset of septic shock).The adverse events were assessed from date of randomization until 60 days after the onset of septic shock or date of death from any cause, whichever came first, assessed up to 60 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Hydrocortisone
Hide Arm/Group 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).
All-Cause Mortality
Placebo Hydrocortisone
Affected / at Risk (%) Affected / at Risk (%)
Total   19/60 (31.67%)   23/58 (39.66%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Hydrocortisone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   1/58 (1.72%) 
Endocrine disorders     
hyperglycemia *  0/60 (0.00%)  1/58 (1.72%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Hydrocortisone
Affected / at Risk (%) Affected / at Risk (%)
Total   2/60 (3.33%)   1/58 (1.72%) 
Musculoskeletal and connective tissue disorders     
muscle weakness *  2/60 (3.33%)  1/58 (1.72%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: QQLv
Organization: Subei People's Hospital
Phone: 18051063899
EMail: bonhomie2014@163.com
Layout table for additonal information
Responsible Party: Qing-quan Lv, Northern Jiangsu Province People's Hospital
ClinicalTrials.gov Identifier: NCT02580240     History of Changes
Other Study ID Numbers: 2015KY-127
First Submitted: October 18, 2015
First Posted: October 20, 2015
Results First Submitted: January 24, 2017
Results First Posted: August 7, 2017
Last Update Posted: August 7, 2017