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The Effect of Moderate-Dose Steroid Therapy in Sepsis

Phase 4
Completed
Conditions
Sepsis
Interventions
Registration Number
NCT01275638
Lead Sponsor
TC Erciyes University
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
55
Inclusion Criteria
  • Patients over 17 years old and diagnosed with sepsis were included in the study consecutively
Exclusion Criteria
  • Already known pre-existing adrenal disease or adrenalectomy, known malignancies, tuberculosis that might have involved the adrenal gland, and administration of steroids within the 3 months before the admission. In addition, patients with burns, hemorrhagic shock or those who had suffered myocardial infarction were not included.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Prednisolone (20 mg/day) for 10 days.Prednisolone-
Primary Outcome Measures
NameTimeMethod
All-cause mortality28-day
Secondary Outcome Measures
NameTimeMethod
Adverse Events28 days
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