HyperglycemiaPhase 4NCT02266264
Hyperglycemia and Effects of Daily 100 mg Versus 200 mg of Hydrocortisone Therapy in Patients With Septic Shock
A Phase 4 study testing Hydrocortisone in people with Hyperglycemia, run by Srinakharinwirot University at 1 site in Thailand.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Hydrocortisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2014to May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Septic shock
- Adequate fluid resuscitation and vasopressor therapy are unable to maintain hemodynamic stability
Who cannot join
- Receive systemic steroid in past 3 months
- Established adrenal insufficiency
- Currently used in chemotherapy or immunosuppressive agents
- Radiotherapy currently received
- Known HIV infection
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Medicine, Faculty of Medicine, Srinakharinwirot University
Ongkharak, Changwat Nakhon Nayok, 26120
About this study
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
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.
- Conditions
- Hyperglycemia
- Being tested
- Hydrocortisone
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Also called solu cortef
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.
| Study group | Role | What they receive |
|---|---|---|
| 100 milligrams of hydrocortisone | Experimental | 100 milligrams per day of hydrocortisone is the starting dosage. Receives: Drug: Hydrocortisone |
| 200 milligrams of hydrocortisone | Active comparator | 200 milligrams per day of hydrocortisone is the starting dosage. Receives: Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperglycemia
Proportion of hyperglycemic patients
Measured: two years
Secondary outcomes (2)
28-day mortality
The number of the patients who died before or at 28 days after enrollment.
Measured: two years
Time to shock reversal
The dates when vasopressors can be stopped.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Srinakharinwirot University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kanchana Ngaosuwan, Srinakharinwirot University
- Investigators
- Kanchana Ngaosuwan, Master, Principal investigator, Department of Medicine, Faculty of Medicine, Srinakharinwirot University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266264
- Sponsor's protocol ID
- MED-R2R-200
- Status last verified
- Oct 2017
- First submitted
- 10 Oct 2014
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02266264
- Acronym / sponsor ID
- MED-R2R-200
- Conditions
- Hyperglycemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Srinakharinwirot UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 milligrams of hydrocortisone | Experimental | Drug: Hydrocortisone100 milligrams per day of hydrocortisone is the starting dosage. |
| 200 milligrams of hydrocortisone | Active comparator | Drug: Hydrocortisone200 milligrams per day of hydrocortisone is the starting dosage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Septic shock
- Adequate fluid resuscitation and vasopressor therapy are unable to maintain hemodynamic stability
Key exclusion criteria (6 listed)
- Receive systemic steroid in past 3 months
- Established adrenal insufficiency
- Currently used in chemotherapy or immunosuppressive agents
- Radiotherapy currently received
- Known HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrocortisoneAlso: solu cortefSubjects 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. | Drug | 100 milligrams of hydrocortisone, 200 milligrams of hydrocortisone |
Primary outcome
Hyperglycemia
Time frame: two years
Proportion of hyperglycemic patients
2 secondary outcomes
28-day mortality
Time frame: two years
Time to shock reversal
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kanchana Ngaosuwan, Master principal investigator
Department of Medicine, Faculty of Medicine, Srinakharinwirot University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone in people with Hyperglycemia, run by Srinakharinwirot University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperglycemia (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.