Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368381
Status:
WITHDRAWN
Last Update Posted:
2012-02-13
First Post:
2006-08-23
Brief Title:
Hydrocortisone Versus Hydrocortisone Plus Fludrocortisone for the Treatment of Adrenal Insufficiency in Severe Sepsis
Sponsor:
CAMC Health System
Organization:
CAMC Health System
Study Overview
Official Title:
A Blinded Placebo Controlled Trial of Hydrocortisone Versus Hydrocortisone Plus Fludrocortisone for the Treatment of Adrenal Insufficiency in Severe Sepsis
Status:
WITHDRAWN
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed for PI failure to submit renewal paperwork
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if the combination of hydrocortisone plus fludrocortisone is more efficacious than hydrocortisone alone in treating adrenal insufficiency in severe sepsis
Detailed Description:
Sepsis is a significant cause of morbidity and mortality in critically ill patients in the United States As evidenced by its increasing prevalence and high mortality rates sepsis is a complex and difficult syndrome to treat Current therapeutic management of sepsis includes fluid resuscitation vasopressor and inotropic support maintenance of oxygen delivery drotrecogin alpha and steroid replacement therapy in patients who are found to have adrenal insufficiency Studies in septic patients suggest that the administration of stress doses of hydrocortisone alone or the combination of hydrocortisone plus fludrocortisone promotes an improvement in cardiovascular performance and a quicker resolution of shock symptoms Current therapeutic guidelines for the treatment of severe sepsis recommend either hydrocortisone alone or combination therapy with hydrocortisone and fludrocortisone as therapeutic options for the treatment of adrenal dysfunction in severe sepsis This study will help determine which regimen is more efficacious in this patient population
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