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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17306016
Publication citations
-
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.