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

Srinakharinwirot University

Status and phase: Completed; Phase 4

Conditions: Hyperglycemia

Treatments: Drug: Hydrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT02266264

MED-R2R-200

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups

100 milligrams of hydrocortisone

Experimental group

Description:

100 milligrams per day of hydrocortisone is the starting dosage.

Treatment:

Drug: Hydrocortisone

200 milligrams of hydrocortisone

Active Comparator group

Description:

200 milligrams per day of hydrocortisone is the starting dosage.

Treatment:

Drug: Hydrocortisone