Hydrocortisone Versus Hydrocortisone Plus Fludrocortisone for the Treatment of Adrenal Insufficiency in Severe Sepsis
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|ClinicalTrials.gov Identifier: NCT00368381|
Recruitment Status : Withdrawn (Study closed for PI failure to submit renewal paperwork)
First Posted : August 24, 2006
Last Update Posted : February 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Adrenal Insufficiency||Drug: Hydrocortisone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Blinded, Placebo Controlled Trial of Hydrocortisone Versus Hydrocortisone Plus Fludrocortisone for the Treatment of Adrenal Insufficiency in Severe Sepsis|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||September 2009|
Active Comparator: Hydrocortision and fludrocortisone
Study is comparing hydrocortisone alone versus the combination of hydrocortisone and fludrocortisone in the treatment of adrenal insufficiency of septic patients.
Patients randomized to this arm will receive hydrocortisone for the treatment of adrenal insufficiency secondary to sepsis.
- All cause mortality [ Time Frame: 28 days ]All cause mortality during first 28-days after study randomization.
- Intensive care unit survival, duration of intensive care unit stay, duration of hospitalization, survival to hospital discharge, time to vasopressor withdrawal [ Time Frame: Unable to define ]The various secondary endpoints are patient specific serrogate markers of improvement in clinical status. Time frame for these endpoints to occur is patient specific and can not be defined for the entire study population.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368381
|Principal Investigator:||John A Bethea, Pharm.D.||Charleston Area Medical Center (CAMC)|