The Effect of Moderate-Dose Steroid Therapy in Sepsis

This study has been completed.
Sponsor:
Information provided by:
TC Erciyes University
ClinicalTrials.gov Identifier:
NCT01275638
First received: January 11, 2011
Last updated: NA
Last verified: April 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Sepsis
Drug: Prednisolone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Moderate-Dose Steroid Therapy in Sepsis: A Placebo-Controlled, Randomized Study

Resource links provided by NLM:


Further study details as provided by TC Erciyes University:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: 28-day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: April 2005
Study Completion Date: May 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Prednisolone (20 mg/day) for 10 days. 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.
Other Names:
  • prednisolon
  • prednizolone

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01275638

Sponsors and Collaborators
TC Erciyes University
Investigators
Study Chair: Bilgehan AYGEN, Prof. Erciyes University Medical Faculty Infectious Diseases Departmen
  More Information

No publications provided

Responsible Party: TC Erciyes University, Erciyes University Medical Faculty
ClinicalTrials.gov Identifier: NCT01275638     History of Changes
Other Study ID Numbers: 03/05
Study First Received: January 11, 2011
Last Updated: January 11, 2011
Health Authority: Erciyes University, Medical Faculty Ethics committee :TURKEY

Keywords provided by TC Erciyes University:
cortisol, prednisolone, adrenal insufficiency, sepsis

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014