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

NCT ID: NCT02266264

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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100 milligrams of hydrocortisone

100 milligrams per day of hydrocortisone is the starting dosage.

Group Type EXPERIMENTAL

Hydrocortisone

Intervention Type 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.

200 milligrams of hydrocortisone

200 milligrams per day of hydrocortisone is the starting dosage.

Group Type ACTIVE_COMPARATOR

Hydrocortisone

Intervention Type 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.

Interventions

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Hydrocortisone

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.

Intervention Type DRUG

Other Intervention Names

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solu cortef

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Srinakharinwirot University

OTHER

Sponsor Role lead

Responsible Party

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Kanchana Ngaosuwan

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kanchana Ngaosuwan, Master

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Faculty of Medicine, Srinakharinwirot University

Locations

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Department of Medicine, Faculty of Medicine, Srinakharinwirot University

Ongkharak, Changwat Nakhon Nayok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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MED-R2R-200

Identifier Type: -

Identifier Source: org_study_id