HCT+F vs. HCT Alone in Critically Ill Medical Septic Shock Patients

Septic Shock Clinical Trial

Official title: Hydrocortisone and Fludrocortisone Versus Hydrocortisone Alone in Critically Ill Medical Patients With Septic Shock

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

• NCT number: NCT03710187
• Study type: Interventional
• Source: University of Tennessee Medical Center
• Status: Completed
• Phase: Phase 2
• Start date: November 5, 2018
• Completion date: September 27, 2019