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Effect of Hydrocortisone Treatment modality on Glycemic Control in patients with Septic Shock
ISRCTN ISRCTN98820688
DOI 10.1186/ISRCTN98820688
ClinicalTrials.gov identifier
EudraCT number
Public title Effect of Hydrocortisone Treatment modality on Glycemic Control in patients with Septic Shock
Scientific title
Acronym HTGCSS
Serial number at source N/A
Study hypothesis Continuous hydrocortisone infusion will reduce the fluctuations in blood glucose levels in septic shock patients when compared to bolus treatment.
Lay summary
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.
Countries of recruitment Finland
Disease/condition/study domain Vasopressor-dependent septic shock
Participants - 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.
Participants - exclusion criteria 1. Patients under 18 years of age
2. Patients with diabetes
3. Patients receiving glucocorticoids
Anticipated start date 05/07/2005
Anticipated end date 30/04/2006
Status of trial Completed
Patient information material
Target number of participants 48
Interventions 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.
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.
Secondary outcome measure(s) Shock reversal during the five day study period and the amount of nursing workload needed to maintain normoglycemia.
Sources of funding 1. Medical Research Fund of Tampere University Hospital (Finland)
2. Medical Research Fund of Päijät-Häme Central Hospital (Finland)
Trial website
Publications Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17306016
Contact name Dr  Esko  Ruokonen
  Address Kuopio University Hospital
PO Box 1777
  City/town Kuopio
  Zip/Postcode 70211
  Country Finland
Sponsor Päijät-Häme Central Hospital (Finland)
  Address Keskussairaalankatu 7
  City/town Lahti
  Zip/Postcode 15850
  Country Finland
  Tel +358 3 81911
  Email pekka.loisa@phks.fi
Date applied 14/09/2006
Last edited 28/11/2007
Date ISRCTN assigned 18/10/2006
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