Hyperglycemia and Effects of Daily 100 mg Versus 200 mg of Hydrocortisone Therapy in Patients With Septic Shock
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2014
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 10, 2014
CompletedFirst Posted
Study publicly available on registry
October 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedOctober 6, 2017
October 1, 2017
2.6 years
October 10, 2014
October 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Hyperglycemia
Proportion of hyperglycemic patients
two years
Secondary Outcomes (2)
28-day mortality
two years
Time to shock reversal
two years
Study Arms (2)
100 milligrams of hydrocortisone
EXPERIMENTAL100 milligrams per day of hydrocortisone is the starting dosage.
200 milligrams of hydrocortisone
ACTIVE COMPARATOR200 milligrams per day of hydrocortisone is the starting dosage.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Septic shock
- Adequate fluid resuscitation and vasopressor therapy are unable to maintain hemodynamic stability
You may not qualify if:
- Receive systemic steroid in past 3 months
- Established adrenal insufficiency
- Currently used in chemotherapy or immunosuppressive agents
- Radiotherapy currently received
- Known HIV infection
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine, Faculty of Medicine, Srinakharinwirot University
Ongkharak, Changwat Nakhon Nayok, 26120, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kanchana Ngaosuwan, Master
Department of Medicine, Faculty of Medicine, Srinakharinwirot University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
October 10, 2014
First Posted
October 17, 2014
Study Start
October 1, 2014
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
October 6, 2017
Record last verified: 2017-10