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The Effect of Moderate-Dose Steroid Therapy in Sepsis

NCT01275638 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2011-01-12

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • TC Erciyes University

    lead OTHER

Principal Investigators

  • Bilgehan AYGEN, Prof. · Erciyes University Medical Faculty Infectious Diseases Departmen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2008-05-31
Completion
2009-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01275638 on ClinicalTrials.gov