Condition category
Signs and Symptoms
Date applied
14/09/2006
Date assigned
18/10/2006
Last edited
28/11/2007
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 Esko Ruokonen

ORCID ID

Contact details

Kuopio University Hospital
PO Box 1777
Kuopio
70211
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

HTGCSS

Study hypothesis

Continuous hydrocortisone infusion will reduce the fluctuations in blood glucose levels in septic shock patients when compared to bolus treatment.

Ethics approval

Ethics commitee of Päijät-Häme Central Hospital, approval gained on 25th February 2005 (Code Q 71).

Study design

Randomised prospective trial. Patients are randomised to receive hydrocortisone either by bolus or by continuous infusion in blocks of four patients. Study is not blinded nor placebo controlled.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Vasopressor-dependent septic shock

Intervention

Septic shock patients who are considered to benefit from the corticosteroid treatment are randomly assigned to receive hydrocortisone either by bolus treament or by continuous infusion with equivalent dose (200 mg/day). During the study period a strict normoglycemic goal is maintained with continuous insulin infusion. Duration of hydrocortisone treatment was five days.

Intervention type

Drug

Phase

Not Specified

Drug names

Hydrocortisone

Primary outcome measures

Mean blood glucose levels in study groups and the number of hyperglycemic (more than 7 mmol/l) and hypoglycemic (less than 3 mmol/l) episodes.

Secondary outcome measures

Shock reversal during the five day study period and the amount of nursing workload needed to maintain normoglycemia.

Overall trial start date

05/07/2005

Overall trial end date

30/04/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Septic shock patients meeting the criteria for septic shock according to the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48

Participant exclusion criteria

1. Patients under 18 years of age
2. Patients with diabetes
3. Patients receiving glucocorticoids

Recruitment start date

05/07/2005

Recruitment end date

30/04/2006

Locations

Countries of recruitment

Finland

Trial participating centre

Kuopio University Hospital
Kuopio
70211
Finland

Sponsor information

Organisation

Päijät-Häme Central Hospital (Finland)

Sponsor details

Keskussairaalankatu 7
Lahti
15850
Finland
+358 3 81911
pekka.loisa@phks.fi

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Medical Research Fund of Tampere University Hospital (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Fund of Päijät-Häme Central Hospital (Finland)

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/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17306016

Publication citations

  1. Results

    Loisa P, Parviainen I, Tenhunen J, Hovilehto S, Ruokonen E, Effect of mode of hydrocortisone administration on glycemic control in patients with septic shock: a prospective randomized trial., Crit Care, 2007, 11, 1, R21, doi: 10.1186/cc5696.

Additional files

Editorial Notes