The Effect of Moderate-Dose Steroid Therapy in Sepsis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Moderate-Dose Steroid Therapy in Sepsis: A Placebo-Controlled, Randomized Study|
- All-cause mortality [ Time Frame: 28-day ] [ Designated as safety issue: Yes ]
- Adverse Events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2005|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Prednisolone (20 mg/day) for 10 days.||
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275638
|Study Chair:||Bilgehan AYGEN, Prof.||Erciyes University Medical Faculty Infectious Diseases Departmen|