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

University of Tennessee Medical Center84 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Septic Shock

Interventions

HydrocortisoneDRUG

Hydrocortisone 50 mg IV Q6h

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Critically ill medical patients requiring addition of stress dose steroid therapy (hydrocortisone) in addition to pressors for septic shock management during ICU stay * Fludrocortisone administered within 24 hours after initiation of hydrocortisone if in combination therapy group Exclusion Criteria: * Use of fludrocortisone and/or hydrocortisone for any reason other than septic shock management during ICU stay * Fludrocortisone/hydrocortisone initiated by any service other than critical care medicine * Prior use of fludrocortisone/hydrocortisone at time of admission (home or outside facility) * Patients not appropriate for study inclusion as determined by provider discretion * Patients receiving steroid therapy not in accordance with assigned group per location (MCC1 or MCC2) * Patients re-admitted to the MCC during the same admission and restarted on vasopressor therapy will be noted during data collection and only the initial admission will be included for analysis * Any patient receiving greater than one dose of hydrocortisone 100 mg * Physical or medical contraindication to receiving PO or PER FT (per feeding tube) fludrocortisone

Locations (1)

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Outcomes

Primary Outcomes

Time to Resolution of Shock

Hours for patient to achieve 24 hours vasopressor free

Time frame: Up to one week

Data from ClinicalTrials.gov

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