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