Condition category
Infections and Infestations
Date applied
15/04/2002
Date assigned
15/04/2002
Last edited
19/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Orhan Yildiz

ORCID ID

Contact details

Erciyes Universitesi Tip Fakültesi
Klinik mikrobiyoloji ve Infeksiyon
Hastaliklari Bilim Dali
Kayseri
38039
Turkey
+90 352 437 49 37
yildizorhan@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol number: 97.02.20; Trial number: 97.013.46

Study information

Scientific title

Acronym

Study hypothesis

The aim of the study was to assess the prognostic importance of basal cortisol concentrations and cortisol response to corticotropin, and to determine the effects of physiological dose steroid therapy on mortality in patients with sepsis.

Ethics approval

The study protocol was approved by the Institutional Review Board of Erciyes University and informed consent was obtained from the patients' relatives.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Sepsis and adrenal insufficiencies

Intervention

Patients enrolled in the study were treated with standard therapy used in the treatment of sepsis and septic shock. This therapy could include administration of antibiotics, fluid replacement, vasoactive drugs, mechanical ventilatory support, and any other form of supportive therapy deemed necessary by the primary physicians.

Soon after the presumptive diagnosis of severe sepsis, an adrenalcorticotropic hormone (ACTH) stimulation test was performed with 250 µg of tetracosactrin (synacthene, Ciba Geigy, Germany) given intravenously and the patients were randomised to treatment with prednisolone or placebo groups. The treatment groups were determined by a computer-generated randomisation procedure.

Steroid therapy group received prednisolone in physiologic doses. Prednisolone was intravenously given 5 mg at 06.00 am, and 2.5 mg at 18.00 pm for ten days.

Standard therapy group received a placebo infusion containing physiologic saline solution in an identical manner.

Patients and their primary physicians were blinded as to which therapy was administered.

Intervention type

Drug

Phase

Not Specified

Drug names

Prednisolone

Primary outcome measures

The primary endpoint of the study was 28-day mortality from all causes.

Secondary outcome measures

The secondary endpoint consisted of adverse occurrences including possible complications of drug therapy and morbid events such as the progression of initial infection and the development of secondary infection. Secondary infection was defined as the identification of a new site of infection or the emergence of a different organism at the same site, generally requiring a change in antibiotic management.

Overall trial start date

01/05/1997

Overall trial end date

01/04/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Patients over 17 years old and diagnosed with sepsis were included in the study consecutively. The diagnosis of sepsis was based on the definition of the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference Report. The severity of illness was classified according to this definition.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

Criteria for exclusion from the study were as follows:
1. Already known pre-existing adrenal disease or adrenalectomy
2. Known malignancies, tuberculosis that might have involved the adrenal gland
3. Administration of steroids within the three months before the admission
4. In addition, patients with burns, hemorrhagic shock or those who had suffered myocardial infarction were not included

Recruitment start date

01/05/1997

Recruitment end date

01/04/1999

Locations

Countries of recruitment

Turkey

Trial participating centre

Erciyes Universitesi Tip Fakültesi
Kayseri
38039
Turkey

Sponsor information

Organisation

Erciyes University (Turkey)

Sponsor details

Tip Fakültesi
Klinik mikrobiyoloji ve Infeksiyon
Hastaliklari Bilim Dali
Kayseri
38039
Turkey

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Erciyes University (Turkey) - research fund (ref: 97.013.46)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/12133187

Publication citations

  1. Results

    Yildiz O, Doganay M, Aygen B, Güven M, Keleştimur F, Tutuû A, Physiological-dose steroid therapy in sepsis [ISRCTN36253388]., Crit Care, 2002, 6, 3, 251-259.

Additional files

Editorial Notes