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Hyperglycemia and Effects of Daily 100 mg Versus 200 mg of Hydrocortisone Therapy in Patients With Septic Shock

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ClinicalTrials.gov Identifier: NCT02266264
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Kanchana Ngaosuwan, Srinakharinwirot University

Brief Summary:
The purpose of this study is to compare hyperglycemia and other effects, include 28-day mortality and time to reversal of shock between 100 milligrams and 200 milligrams of hydrocortisone as initial dosage in patients with septic shock.

Condition or disease Intervention/treatment Phase
Hyperglycemia Drug: Hydrocortisone Phase 4

Detailed Description:

The intervention group will be received 100 milligrams per day of hydrocortisone on the first three day the taper off, whereas the control group will be received 200 milligrams per day of hydrocortisone on the first three day the taper off. Hyperglycemia rate will be monitored every 6 hours after hydrocortisone is started until 24 hours after it is stopped.

Also, 28-day mortality will be follow after hydrocortisone is started.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Hyperglycemia and Effects of Daily 100 Milligrams Versus 200 Milligrams of Hydrocortisone Therapy in Patients With Septic Shock: A Double-Blind Randomized Controlled Trial
Study Start Date : October 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017


Arm Intervention/treatment
Experimental: 100 milligrams of hydrocortisone
100 milligrams per day of hydrocortisone is the starting dosage.
Drug: Hydrocortisone
Subjects will be divided into two groups by randomization. The intervention-group will be received 100 milligrams per day of hydrocortisone and the control-group will be received 200 milligrams per day of hydrocortisone in the first three days after enrollment.
Other Name: solu cortef

Active Comparator: 200 milligrams of hydrocortisone
200 milligrams per day of hydrocortisone is the starting dosage.
Drug: Hydrocortisone
Subjects will be divided into two groups by randomization. The intervention-group will be received 100 milligrams per day of hydrocortisone and the control-group will be received 200 milligrams per day of hydrocortisone in the first three days after enrollment.
Other Name: solu cortef




Primary Outcome Measures :
  1. Hyperglycemia [ Time Frame: two years ]
    Proportion of hyperglycemic patients


Secondary Outcome Measures :
  1. 28-day mortality [ Time Frame: two years ]
    The number of the patients who died before or at 28 days after enrollment.

  2. Time to shock reversal [ Time Frame: two years ]
    The dates when vasopressors can be stopped.



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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:

  • Septic shock
  • Adequate fluid resuscitation and vasopressor therapy are unable to maintain hemodynamic stability

Exclusion Criteria:

  • Receive systemic steroid in past 3 months
  • Established adrenal insufficiency
  • Currently used in chemotherapy or immunosuppressive agents
  • Radiotherapy currently received
  • Known HIV infection
  • Pregnancy

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): NCT02266264


Locations
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Thailand
Department of Medicine, Faculty of Medicine, Srinakharinwirot University
Ongkharak, Nakhon nayok, Thailand, 26120
Sponsors and Collaborators
Srinakharinwirot University
Investigators
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Principal Investigator: Kanchana Ngaosuwan, Master Department of Medicine, Faculty of Medicine, Srinakharinwirot University

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Responsible Party: Kanchana Ngaosuwan, Doctor, Srinakharinwirot University
ClinicalTrials.gov Identifier: NCT02266264     History of Changes
Other Study ID Numbers: MED-R2R-200
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Shock, Septic
Hyperglycemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Glucose Metabolism Disorders
Metabolic Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents