Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147004
Status:
COMPLETED
Last Update Posted:
2008-04-24
First Post:
2005-09-06
Brief Title:
Corticosteroid Therapy of Septic Shock - Corticus
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Corticosteroid Therapy of Septic Shock - Corticus A Multi-National Prospective Double-Blind Randomized Placebo-Controlled Study
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Corticus
Brief Summary:
The purpose of the study is to determine whether steroids decrease 28-day mortality in patients with septic shock
Detailed Description:
The use of steroids in septic shock remains controversial The purpose of this study is to determine whether hydrocortisone decreases 28-day mortality in patients with septic shock The primary end point will be 28-day mortality in all the non-responders to ACTH or 9 mcgdl or 250 nmolL post ACTH Secondary endpoints will be 28 day all cause mortality in the total group and in responders ICU and hospital mortality one year mortality organ system failure reversal especially shock and duration of ICU and total hospitalisation
In a double-blinded fashion randomized on a 11 basis patients receive 50 mg intravenously every 6 hours for 5 days After 5 days treatment will be tapered with 50 mg given intravenously every 12 hours for days 6-8 then 50 mg every 24 hours for days 9-11 and then stopped
All concomitant treatments including antibiotics fluids vasopressors and ancillary therapies will be given at the discretion of the primary care physician Evidence-based guidelines for the management of severe sepsis and septic shock by the International Sepsis Forum Intensive Care Med 200127S124-S134 are encouraged to be followed
All serious adverse events SAE which occur between days 0 and 28 which are unexpected andor considered possibly or probably related to the study medication must be documented and reported within 24 hours to the Safety and Efficacy Monitoring Committee Non-serious adverse events will be listed on the case report form if they are unexpected and believed to be related to the study drug during days 0 to 14
Specific adverse events which will be monitored closely because of their relationship to corticosteroids and shock are
1 Use of corticosteroids ie gastrointestinal bleeding and superinfection hyperglycemia hypernatremia muscular weakness etc
2 Shock and use of vasopressors ie stroke acute myocardial infarction and peripheral ischemia
In addition substudies will include harmonization of cortisol by comparing cortisol levels measured in local laboratories and a central laboratory immune and neuro-endocrine interactions neuromuscular weakness and cytokines
In a double-blinded fashion randomized on a 11 basis patients receive 50 mg intravenously every 6 hours for 5 days After 5 days treatment will be tapered with 50 mg given intravenously every 12 hours for days 6-8 then 50 mg every 24 hours for days 9-11 and then stopped
All concomitant treatments including antibiotics fluids vasopressors and ancillary therapies will be given at the discretion of the primary care physician Evidence-based guidelines for the management of severe sepsis and septic shock by the International Sepsis Forum Intensive Care Med 200127S124-S134 are encouraged to be followed
All serious adverse events SAE which occur between days 0 and 28 which are unexpected andor considered possibly or probably related to the study medication must be documented and reported within 24 hours to the Safety and Efficacy Monitoring Committee Non-serious adverse events will be listed on the case report form if they are unexpected and believed to be related to the study drug during days 0 to 14
Specific adverse events which will be monitored closely because of their relationship to corticosteroids and shock are
1 Use of corticosteroids ie gastrointestinal bleeding and superinfection hyperglycemia hypernatremia muscular weakness etc
2 Shock and use of vasopressors ie stroke acute myocardial infarction and peripheral ischemia
In addition substudies will include harmonization of cortisol by comparing cortisol levels measured in local laboratories and a central laboratory immune and neuro-endocrine interactions neuromuscular weakness and cytokines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EC- QLK2-CT-2000-00589 | None | None | None |