Physiological dose steroid therapy in sepsis
| ISRCTN | ISRCTN36253388 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36253388 |
| Secondary identifying numbers | Protocol number: 97.02.20; Trial number: 97.013.46 |
- Submission date
- 15/04/2002
- Registration date
- 15/04/2002
- Last edited
- 19/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Orhan Yildiz
Scientific
Scientific
Erciyes Universitesi Tip Fakültesi
Klinik mikrobiyoloji ve Infeksiyon
Hastaliklari Bilim Dali
Kayseri
38039
Türkiye
| Phone | +90 352 437 49 37 |
|---|---|
| yildizorhan@hotmail.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The aim of the study was to assess the prognostic importance of basal cortisol concentrations and cortisol response to corticotropin, and to determine the effects of physiological dose steroid therapy on mortality in patients with sepsis. |
| Ethics approval(s) | The study protocol was approved by the Institutional Review Board of Erciyes University and informed consent was obtained from the patients' relatives. |
| Health condition(s) or problem(s) studied | Sepsis and adrenal insufficiencies |
| Intervention | Patients enrolled in the study were treated with standard therapy used in the treatment of sepsis and septic shock. This therapy could include administration of antibiotics, fluid replacement, vasoactive drugs, mechanical ventilatory support, and any other form of supportive therapy deemed necessary by the primary physicians. Soon after the presumptive diagnosis of severe sepsis, an adrenalcorticotropic hormone (ACTH) stimulation test was performed with 250 µg of tetracosactrin (synacthene, Ciba Geigy, Germany) given intravenously and the patients were randomised to treatment with prednisolone or placebo groups. The treatment groups were determined by a computer-generated randomisation procedure. Steroid therapy group received prednisolone in physiologic doses. Prednisolone was intravenously given 5 mg at 06.00 am, and 2.5 mg at 18.00 pm for ten days. Standard therapy group received a placebo infusion containing physiologic saline solution in an identical manner. Patients and their primary physicians were blinded as to which therapy was administered. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Prednisolone |
| Primary outcome measure | The primary endpoint of the study was 28-day mortality from all causes. |
| Secondary outcome measures | The secondary endpoint consisted of adverse occurrences including possible complications of drug therapy and morbid events such as the progression of initial infection and the development of secondary infection. Secondary infection was defined as the identification of a new site of infection or the emergence of a different organism at the same site, generally requiring a change in antibiotic management. |
| Overall study start date | 01/05/1997 |
| Completion date | 01/04/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | Patients over 17 years old and diagnosed with sepsis were included in the study consecutively. The diagnosis of sepsis was based on the definition of the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference Report. The severity of illness was classified according to this definition. |
| Key exclusion criteria | Criteria for exclusion from the study were as follows: 1. Already known pre-existing adrenal disease or adrenalectomy 2. Known malignancies, tuberculosis that might have involved the adrenal gland 3. Administration of steroids within the three months before the admission 4. In addition, patients with burns, hemorrhagic shock or those who had suffered myocardial infarction were not included |
| Date of first enrolment | 01/05/1997 |
| Date of final enrolment | 01/04/1999 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Erciyes Universitesi Tip Fakültesi
Kayseri
38039
Türkiye
38039
Türkiye
Sponsor information
Erciyes University (Turkey)
University/education
University/education
Tip Fakültesi
Klinik mikrobiyoloji ve Infeksiyon
Hastaliklari Bilim Dali
Kayseri
38039
Türkiye
"ROR" |
https://ror.org/047g8vk19 |
|---|
Funders
Funder type
University/education
Erciyes University (Turkey) - research fund (ref: 97.013.46)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/06/2002 | Yes | No |
