A Phase 4 interventional study of Prednisolone in Sepsis, sponsored by TC Erciyes University. Completed. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2011-01-12.
Sponsored by TC Erciyes University · Phase 4, Interventional, and Treatment
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.
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 55 is below the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →TC Erciyes University is the lead sponsor of 341 studies on the registry; 76 are open to participants now.
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Drug: Prednisolone
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.
Also known as: prednisolon, prednizolone
All-cause mortality
Time frame: 28-day
Adverse Events
Time frame: 28 days
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This study is completed, as verified in Apr 2005. You cannot join it, but the record below documents what was studied.
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TC Erciyes University