Effect of Hydrocortisone Treatment modality on Glycemic Control in patients with Septic Shock

ISRCTN ISRCTN98820688
DOI https://doi.org/10.1186/ISRCTN98820688
Secondary identifying numbers N/A
Submission date
14/09/2006
Registration date
18/10/2006
Last edited
28/11/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Esko Ruokonen
Scientific

Kuopio University Hospital
PO Box 1777
Kuopio
70211
Finland

Study information

Study designRandomised 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 designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymHTGCSS
Study objectivesContinuous hydrocortisone infusion will reduce the fluctuations in blood glucose levels in septic shock patients when compared to bolus treatment.
Ethics approval(s)Ethics commitee of Päijät-Häme Central Hospital, approval gained on 25th February 2005 (Code Q 71).
Health condition(s) or problem(s) studiedVasopressor-dependent septic shock
InterventionSeptic 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Hydrocortisone
Primary outcome measureMean 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 measuresShock reversal during the five day study period and the amount of nursing workload needed to maintain normoglycemia.
Overall study start date05/07/2005
Completion date30/04/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants48
Key inclusion criteriaSeptic shock patients meeting the criteria for septic shock according to the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference.
Key exclusion criteria1. Patients under 18 years of age
2. Patients with diabetes
3. Patients receiving glucocorticoids
Date of first enrolment05/07/2005
Date of final enrolment30/04/2006

Locations

Countries of recruitment

  • Finland

Study participating centre

Kuopio University Hospital
Kuopio
70211
Finland

Sponsor information

Päijät-Häme Central Hospital (Finland)
Hospital/treatment centre

Keskussairaalankatu 7
Lahti
15850
Finland

Phone +358 3 81911
Email pekka.loisa@phks.fi
ROR logo "ROR" https://ror.org/02v92t976

Funders

Funder type

Hospital/treatment centre

Medical Research Fund of Tampere University Hospital (Finland)

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/01/2007 Yes No