The Effect of Moderate-Dose Steroid Therapy in Sepsis

NCT01275638 | Completed Phase 4 DMC

• 1 other identifier: 03/05
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis

Keywords

cortisol, prednisolone, adrenal insufficiency, sepsis

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  28-day

Secondary Outcomes (1)

• Adverse Events

  28 days

Study Arms (1)

Prednisolone (20 mg/day) for 10 days.

PLACEBO COMPARATOR

Drug: Prednisolone

Interventions

Prednisolone DRUG

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

Prednisolone (20 mg/day) for 10 days.

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 17 years old and diagnosed with sepsis were included in the study consecutively

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

MeSH Terms

Conditions

Sepsis; Adrenal Insufficiency

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bilgehan AYGEN, Prof.

  Erciyes University Medical Faculty Infectious Diseases Departmen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2011
• First Posted: January 12, 2011
• Study Start: April 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2009
• Last Updated: January 12, 2011

Record last verified: 2005-04