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

Condition(s) targeted: Hyperglycemia

Intervention: Hydrocortisone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Srinakharinwirot University

Official(s) and/or principal investigator(s):
Kanchana Ngaosuwan, Master, Principal Investigator, Affiliation: Department of Medicine, Faculty of Medicine, Srinakharinwirot University

Overall contact:
Kanchana Ngoasuwan, Master, Phone: +6637 395085, Ext: 11001, Email: Dream.kanchana@gmail.com

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.

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: Hyperglycemia

Secondary outcome:

28-day mortality

Time to shock reversal

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Kanchana Ngoasuwan, Master, Phone: +6637 395085, Ext: 11001, Email: Dream.kanchana@gmail.com

Department of Medicine, Faculty of Medicine, Srinakharinwirot University, Ongkharak, Nakhon nayok 26120, Thailand; Recruiting
Kanchana Ngaosuwan, Phone: +6637 395085, Ext: 11001, Email: Dream.kanchana@gmail.com

Starting date: October 2014
Last updated: May 18, 2015