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

Hyperglycemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266264
• Other study ID #: MED-R2R-200
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2014
• Last updated: October 4, 2017
• Start date: October 2014
• Est. completion date: May 2017

Study information

• Verified date: October 2017
• Source: Srinakharinwirot University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia
• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
Thailand	Department of Medicine, Faculty of Medicine, Srinakharinwirot University	Ongkharak	Nakhon nayok

Sponsors (1)

Lead Sponsor	Collaborator
Srinakharinwirot University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyperglycemia	Proportion of hyperglycemic patients	two years
Secondary	28-day mortality	The number of the patients who died before or at 28 days after enrollment.	two years
Secondary	Time to shock reversal	The dates when vasopressors can be stopped.	two years