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
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
70211
Finland
Sponsor information
Päijät-Häme Central Hospital (Finland)
Hospital/treatment centre
Hospital/treatment centre
Keskussairaalankatu 7
Lahti
15850
Finland
Phone | +358 3 81911 |
---|---|
pekka.loisa@phks.fi | |
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 |