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Physiological dose steroid therapy in sepsis
ISRCTN ISRCTN36253388
DOI 10.1186/ISRCTN36253388
ClinicalTrials.gov identifier
EudraCT number
Public title Physiological dose steroid therapy in sepsis
Scientific title
Acronym N/A
Serial number at source Protocol number: 97.02.20; Trial number: 97.013.46
Study hypothesis 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.
Lay summary
Ethics approval The study protocol was approved by the Institutional Review Board of Erciyes University and informed consent was obtained from the patients' relatives.
Study design Randomised controlled trial
Countries of recruitment Turkey
Disease/condition/study domain Sepsis and adrenal insufficiencies
Participants - 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.
Participants - 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
Anticipated start date 01/05/1997
Anticipated end date 01/04/1999
Status of trial Completed
Patient information material
Target number of participants 40
Interventions 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.
Primary outcome measure(s) The primary endpoint of the study was 28-day mortality from all causes.
Secondary outcome measure(s) 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.
Sources of funding Erciyes University (Turkey) - research fund (ref: 97.013.46)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/12133187
Contact name Dr  Orhan  Yildiz
  Address Erciyes Universitesi Tip Fakültesi
Klinik mikrobiyoloji ve Infeksiyon
Hastaliklari Bilim Dali
  City/town Kayseri
  Zip/Postcode 38039
  Country Turkey
  Tel +90 352 437 49 37
  Fax +90 352 437 8553
  Email yildizorhan@hotmail.com
Sponsor Erciyes University (Turkey)
  Address Tip Fakültesi
Klinik mikrobiyoloji ve Infeksiyon
Hastaliklari Bilim Dali
  City/town Kayseri
  Zip/Postcode 38039
  Country Turkey
Date applied 15/04/2002
Last edited 19/02/2008
Date ISRCTN assigned 15/04/2002
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