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

University of Tennessee Medical Center

Status and phase

Completed

Phase 2

Conditions

Septic Shock

Treatments

Drug: Hydrocortisone

Study type

Interventional

Funder types

Other

Identifiers

NCT03710187

UHS-CC-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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