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Completed

NCT Number: NCT02266264

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

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.

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Key information

Conditions

Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Medicine, Faculty of Medicine, Srinakharinwirot University

Ongkharak, Changwat Nakhon Nayok, 26120, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocortisone

Drug

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.

Other names: solu cortef

Primary outcomes

  1. Hyperglycemia

    Time frame: two years

    Proportion of hyperglycemic patients

Secondary outcomes

  1. 28-day mortality

    Time frame: two years

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

  2. Time to shock reversal

    Time frame: two years

    The dates when vasopressors can be stopped.

Sponsors and collaborators

Lead sponsor

Srinakharinwirot University

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2014
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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