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

Primary Purpose

Hyperglycemia

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Hydrocortisone

About this trial

This is an interventional treatment trial for Hyperglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Medicine, Faculty of Medicine, Srinakharinwirot University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

100 milligrams of hydrocortisone

200 milligrams of hydrocortisone

Arm Description

100 milligrams per day of hydrocortisone is the starting dosage.

200 milligrams per day of hydrocortisone is the starting dosage.

Outcomes

Primary Outcome Measures

Hyperglycemia

Proportion of hyperglycemic patients

Secondary Outcome Measures

28-day mortality

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

Time to shock reversal

The dates when vasopressors can be stopped.

Full Information

NCT ID

NCT02266264

First Posted

October 10, 2014

Last Updated

October 4, 2017

Sponsor

Srinakharinwirot University

1. Study Identification

Unique Protocol Identification Number

NCT02266264

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Srinakharinwirot University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperglycemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

100 milligrams of hydrocortisone

Arm Type

Experimental

Arm Description

100 milligrams per day of hydrocortisone is the starting dosage.

Arm Title

200 milligrams of hydrocortisone

Arm Type

Active Comparator

Arm Description

200 milligrams per day of hydrocortisone is the starting dosage.

Intervention Type

Drug

Intervention Name(s)

Hydrocortisone

Other Intervention Name(s)

solu cortef

Intervention Description

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.

Primary Outcome Measure Information:

Title

Hyperglycemia

Description

Proportion of hyperglycemic patients

Time Frame

two years

Secondary Outcome Measure Information:

Title

28-day mortality

Description

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

Time Frame

two years

Title

Time to shock reversal

Description

The dates when vasopressors can be stopped.

Time Frame

two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kanchana Ngaosuwan, Master

Organizational Affiliation

Department of Medicine, Faculty of Medicine, Srinakharinwirot University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Medicine, Faculty of Medicine, Srinakharinwirot University

City

Ongkharak

State/Province

Nakhon nayok

ZIP/Postal Code

26120

Country

Thailand

12. IPD Sharing Statement

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

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