The Effect of Moderate-Dose Steroid Therapy in Sepsis

Sepsis Clinical Trial

Official title:

The Effect of Moderate-Dose Steroid Therapy in Sepsis: A Placebo-Controlled, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275638
• Other study ID #: 03/05
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2011
• Last updated: January 11, 2011
• Start date: April 2005
• Est. completion date: May 2009

Study information

• Verified date: April 2005
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		28-day
Secondary	Adverse Events		28 days