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CompletedNCT02266264Updated Oct 6, 2017

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

A Phase 4 interventional study of Hydrocortisone in Hyperglycemia, sponsored by Srinakharinwirot University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-06.

Sponsored by Srinakharinwirot University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hyperglycemia

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03

In context

Hyperglycemia

699 studies on the registry are indexed under Hyperglycemia; 105 are open to participants now.

This study's enrollment of 80 is above the median of 46 across 521 interventional studies indexed under Hyperglycemia.

Browse Hyperglycemia studies →

Lead sponsor

Srinakharinwirot University is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Septic shock
  • Adequate fluid resuscitation and vasopressor therapy are unable to maintain hemodynamic stability

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    100 milligrams of hydrocortisone

    100 milligrams per day of hydrocortisone is the starting dosage.

    Drug: Hydrocortisone

  • Active comparator
    200 milligrams of hydrocortisone

    200 milligrams per day of hydrocortisone is the starting dosage.

    Drug: Hydrocortisone

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.

    Also known as: solu cortef

06

What researchers measure

Primary outcomes

  1. Hyperglycemia

    Proportion of hyperglycemic patients

    Time frame: two years

Secondary outcomes

  1. 28-day mortality

    The number of the patients who died before or at 28 days after enrollment.

    Time frame: two years

  2. Time to shock reversal

    The dates when vasopressors can be stopped.

    Time frame: two years

07

Study locations

1 site
  • Department of Medicine, Faculty of Medicine, Srinakharinwirot University
    Ongkharak, Nakhon nayok 26120, Thailand
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02266264
Lead sponsor
Srinakharinwirot University
Responsible party
Kanchana Ngaosuwan (Doctor, Srinakharinwirot University) — Principal investigator
First posted
Oct 17, 2014
Start date
Oct 2014
Primary completion
May 2017
Completion
May 2017
Last update
Oct 6, 2017

Study contacts

Kanchana Ngaosuwan, Master
principal investigator · Department of Medicine, Faculty of Medicine, Srinakharinwirot University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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