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Hemodynamic and Inflammatory Effects of Abrupt Versus Tapered Corticosteroid Discontinuation in Septic Shock

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ClinicalTrials.gov Identifier: NCT01150409
Recruitment Status : Terminated (Difficulty in recruiting eligible subjects)
First Posted : June 25, 2010
Results First Posted : September 2, 2015
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

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: Normal Saline
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hydrocortisone Normal Saline (Placebo)
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Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)

hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)

Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)

0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)

Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)

Period Title: Overall Study
Started 11 0
Completed 11 0
Not Completed 0 0
Arm/Group Title Hydrocortisone Normal Saline (Placebo) Total
Hide Arm/Group Description

Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)

hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)

Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)

0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)

Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)

Total of all reporting groups
Overall Number of Baseline Participants 11 0 11
Hide Baseline Analysis Population Description
Adult MICU pateints who meet criteria for corticosteroid therapy of septic shock
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 0 participants 11 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  81.8%
9
  81.8%
>=65 years
2
  18.2%
2
  18.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 0 participants 11 participants
Female
5
  45.5%
5
  45.5%
Male
6
  54.5%
6
  54.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 0 participants 11 participants
11 11
1.Primary Outcome
Title Incidence of Hypotension Between Study Days 8 and 14 (Within 7 Days of the Initiation of Study Drug).
Hide Description Study screening/enrollment stopped due to lack of eligible subjects. No outcome measures were analyzed due to the low enrollment.
Time Frame Day 14
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydrocortisone Normal Saline (Placebo)
Hide Arm/Group Description:

Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)

hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)

Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)

0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)

Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hydrocortisone Normal Saline (Placebo)
Hide Arm/Group Description

Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)

hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)

Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)

0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)

Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)

All-Cause Mortality
Hydrocortisone Normal Saline (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Hydrocortisone Normal Saline (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/11 (81.82%)      0/0    
Gastrointestinal disorders     
End Stage Liver Disease   3/11 (27.27%)  3 0/0  0
General disorders     
Septic Shock/Multi System Organ Failure   2/11 (18.18%)  2 0/0  0
Septic Shock/Poor Prognosis/Family Reuest to Withdraw Support   2/11 (18.18%)  2 0/0  0
Respiratory Failure   1/11 (9.09%)  1 0/0  0
ARDS/H1N1   1/11 (9.09%)  1 0/0  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hydrocortisone Normal Saline (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/0    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jorge Guzman MD
Organization: The Cleveland Clinic Foundation
Phone: 216-445-5765
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01150409     History of Changes
Other Study ID Numbers: 08-336
First Submitted: June 21, 2010
First Posted: June 25, 2010
Results First Submitted: August 25, 2015
Results First Posted: September 2, 2015
Last Update Posted: April 2, 2018