Effect of Hydrocortisone Treatment modality on Glycemic Control in patients with Septic Shock
| ISRCTN | ISRCTN98820688 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98820688 |
| Protocol serial number | N/A |
| Sponsor | Päijät-Häme Central Hospital (Finland) |
| Funders | Medical Research Fund of Tampere University Hospital (Finland), Medical Research Fund of Päijät-Häme Central Hospital (Finland) |
- 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
| Primary study design | Interventional |
|---|---|
| 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. |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Hydrocortisone |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Shock reversal during the five day study period and the amount of nursing workload needed to maintain normoglycemia. |
| Completion date | 30/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
