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

• Status: Completed
• Trial end date: 2019-09-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Tennessee Medical Center
• Treatments: Cortisol succinate; Fludrocortisone; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

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