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

Phase 4

Completed

• Conditions: Hyperglycemia
• Interventions: Drug: Hydrocortisone

• Registration Number: NCT02266264
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-17
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
100 milligrams of hydrocortisone	Hydrocortisone	100 milligrams per day of hydrocortisone is the starting dosage.
200 milligrams of hydrocortisone	Hydrocortisone	200 milligrams per day of hydrocortisone is the starting dosage.

Primary Outcome Measures

Name	Time	Method
Hyperglycemia	two years	Proportion of hyperglycemic patients

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Medicine, Faculty of Medicine, Srinakharinwirot University; 🇹🇭 Ongkharak, Nakhon nayok, Thailand