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The Effect of Moderate-Dose Steroid Therapy in Sepsis

T

TC Erciyes University

Status and phase

Completed
Phase 4

Conditions

Sepsis

Treatments

Drug: Prednisolone

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

17+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

55 participants in 1 patient group, including a placebo group

Prednisolone (20 mg/day) for 10 days.
Placebo Comparator group
Treatment:
Drug: Prednisolone

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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