Ignite Creation Date:
2024-05-06 @ 12:15 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03710187
Status:
COMPLETED
Last Update Posted:
2021-05-20
First Post:
2018-10-15
Brief Title:
HCTF vs HCT Alone in Critically Ill Medical Septic Shock Patients
Sponsor:
University of Tennessee Medical Center
Organization:
University of Tennessee Medical Center
Study Overview
Official Title:
Hydrocortisone and Fludrocortisone Versus Hydrocortisone Alone in Critically Ill Medical Patients With Septic Shock
Status:
COMPLETED
Status Verified Date:
2021-04
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:
None
Brief Summary:
This study will be conducted as a single-center prospective open-label randomized trial that will evaluate adult patients admitted with septic shock to the medical critical care unit MCC The objective of the study is to determine if the use of hydrocortisone plus fludrocortisone is associated with a faster resolution of shock defined as 24 hours vasopressor free when compared to the use of hydrocortisone alone in medical critically ill septic shock patients
Detailed Description:
For three consecutive months side 1 of the medical critical care unit MCC1 will receive hydrocortisone alone and side 2 MCC2 will receive the combination of hydrocortisone and fludrocortisone After the initial three months this will be flipped and patients admitted to MCC1 will receive the combination while patients in MCC2 will receive hydrocortisone alone for three consecutive months This change in group assignments will occur to account for the difference in number of beds between MCC1 and MCC2 and to minimize the potential differences in patient acuity by location
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None