The Effect of Moderate-Dose Steroid Therapy in Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01275638
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : January 12, 2011
Information provided by:
TC Erciyes University

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.

Condition or disease Intervention/treatment Phase
Sepsis Drug: Prednisolone Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Moderate-Dose Steroid Therapy in Sepsis: A Placebo-Controlled, Randomized Study
Study Start Date : April 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 28-day ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 28 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01275638

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

Responsible Party: TC Erciyes University, Erciyes University Medical Faculty Identifier: NCT01275638     History of Changes
Other Study ID Numbers: 03/05
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: January 12, 2011
Last Verified: April 2005

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

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents