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 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
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	HTGCSS
Study objectives	Continuous 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) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	05/07/2005
Completion date	30/04/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	48
Key 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.
Key exclusion criteria	1. Patients under 18 years of age 2. Patients with diabetes 3. Patients receiving glucocorticoids
Date of first enrolment	05/07/2005
Date of final enrolment	30/04/2006

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"	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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not 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