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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02266264

Enrollment

Registered

2014-10-17

Start date

2014-10-31

Completion date

2017-05-31

Last updated

2017-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia

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.

Interventions

DRUGHydrocortisone

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Hyperglycemia	two years	Proportion of hyperglycemic patients

Secondary

Measure	Time frame	Description
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.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026