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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Hyperglycemia and Effects of Daily 100 Milligrams Versus 200 Milligrams of Hydrocortisone Therapy in Patients With Septic Shock: A Double-Blind Randomized Controlled Trial

Conditions
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Hyperglycemia

Intervention / Treatment
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* Drug: Hydrocortisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100 milligrams of hydrocortisone<br>100 milligrams per day of hydrocortisone is the starting dosage. | Drug: Hydrocortisone<br>* 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.<br>* Other names: solu cortef;|
| Active Comparator: 200 milligrams of hydrocortisone<br>200 milligrams per day of hydrocortisone is the starting dosage. | Drug: Hydrocortisone<br>* 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.<br>* Other names: solu cortef;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperglycemia | Proportion of hyperglycemic patients | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | The number of the patients who died before or at 28 days after enrollment. | two years | 
| Time to shock reversal | The dates when vasopressors can be stopped. | two years |