SepsisPhase 4NCT01275638
The Effect of Moderate-Dose Steroid Therapy in Sepsis
A Phase 4 study testing Prednisolone in people with Sepsis, run by TC Erciyes University.
Trial summary
Despite the new developments in sepsis treatment, mortality rate is still high. Discussions on steroid treatment in sepsis are going on. In this study, we aimed to investigate the effects of moderate dosage steroid treatment and endocrinologic changes occurring in sepsis on prognosis in patients with sepsis. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Prednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to May 2009
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over 17 years old and diagnosed with sepsis were included in the study consecutively
Who cannot join
- Already known pre-existing adrenal disease or adrenalectomy, known malignancies, tuberculosis that might have involved the adrenal gland, and administration of steroids within the 3 months before the admission. In addition, patients with burns, hemorrhagic shock or those who had suffered myocardial infarction were not included.
About this study
Official title: The Effect of Moderate-Dose Steroid Therapy in Sepsis: A Placebo-Controlled, Randomized Study
Despite the new developments in sepsis treatment, mortality rate is still high. Discussions on steroid treatment in sepsis are going on. In this study, we aimed to investigate the effects of moderate dosage steroid treatment and endocrinologic changes occurring in sepsis on prognosis in patients with sepsis.
Read the detailed description
This prospective, randomized, single-centre, double-blind, placebo-controlled trial was conducted between April 2005 and May 2008 in the department of Medical ICU and the Department of Infectious Diseases of Erciyes University Medical School. The study was approved by our Institutional Review Board and informed consent was obtained from the patients' relatives. The study did not alter therapy, and each patient's clinical care was determined by their own physician.
- Conditions
- Sepsis
- Being tested
- Prednisolone
- Keywords
- cortisol, prednisolone, adrenal insufficiency, sepsis
- Medical subject headings
- Sepsis, Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Also called prednisolon, prednizolone
Soon after the presumptive diagnosis of severe sepsis, initial laboratory specimens were obtained within 2 hours, and the patients were randomized to treatment with prednisolone or placebo groups. The treatment groups were determined by a computer-generated randomization procedure (in a 1:1 ratio). The steroid group received prednisolone at a moderate-dose (20 mg/day). Prednisolone was given intravenously at 06.00 (10 mg) 14.00 (5 mg) and 22.00 (5 mg) for 10 days. The standard therapy group received a placebo infusion containing physiological saline solution in an identical manner. Patients and their primary physicians were blinded as to which therapy was administered.
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone (20 mg/day) for 10 days. | Placebo comparator | Not described Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 28-day
Secondary outcomes (1)
Adverse Events
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startApr 2005
- Primary completionMay 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Investigators
- Bilgehan AYGEN, Prof., Study chair, Erciyes University Medical Faculty Infectious Diseases Departmen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275638
- Sponsor's protocol ID
- 03/05
- Status last verified
- Apr 2005
- First submitted
- 11 Jan 2011
- Last updated
- 12 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Moderate-Dose Steroid Therapy in Sepsis: A Placebo-Controlled, Randomized Study
- ClinicalTrials.gov ID
- NCT01275638
- Acronym / sponsor ID
- 03/05
- Conditions
- Sepsis
- Keywords
- cortisol, prednisolone, adrenal insufficiency, sepsis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 12 Jan 2011 (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.
Despite the new developments in sepsis treatment, mortality rate is still high. Discussions on steroid treatment in sepsis are going on. In this study, we aimed to investigate the effects of moderate dosage steroid treatment and endocrinologic changes occurring in sepsis on prognosis in patients with sepsis.
Detailed description
This prospective, randomized, single-centre, double-blind, placebo-controlled trial was conducted between April 2005 and May 2008 in the department of Medical ICU and the Department of Infectious Diseases of Erciyes University Medical School. The study was approved by our Institutional Review Board and informed consent was obtained from the patients' relatives. The study did not alter therapy, and each patient's clinical care was determined by their own physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prednisolone (20 mg/day) for 10 days. | Placebo comparator | Drug: Prednisolone |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 17 years old and diagnosed with sepsis were included in the study consecutively
Key exclusion criteria (1 listed)
- Already known pre-existing adrenal disease or adrenalectomy, known malignancies, tuberculosis that might have involved the adrenal gland, and administration of steroids within the 3 months before the admission. In addition, patients with burns, hemorrhagic shock or those who had suffered myocardial infarction were not included.
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 |
|---|---|---|
| PrednisoloneAlso: prednisolon, prednizoloneSoon after the presumptive diagnosis of severe sepsis, initial laboratory specimens were obtained within 2 hours, and the patients were randomized to treatment with prednisolone or placebo groups. The treatment groups were determined by a computer-generated randomization procedure (in a 1:1 ratio). The steroid group received prednisolone at a moderate-dose (20 mg/day). Prednisolone was given intravenously at 06.00 (10 mg) 14.00 (5 mg) and 22.00 (5 mg) for 10 days. The standard therapy group received a placebo infusion containing physiological saline solution in an identical manner. Patients and their primary physicians were blinded as to which therapy was administered. | Drug | Prednisolone (20 mg/day) for 10 days. |
Primary outcome
All-cause mortality
Time frame: 28-day
1 secondary outcome
Adverse Events
Time frame: 28 days
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 12 Jan 2011.
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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.
Bilgehan AYGEN, Prof. study chair
Erciyes University Medical Faculty Infectious Diseases Departmen
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone in people with Sepsis, run by TC Erciyes University.
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 1 inclusion and 1 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 12 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
All-cause mortality (time frame: 28-day). 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 12 Jan 2011.