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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03710187
• Other study ID #: UHS-CC-002
• Status: Completed
• Phase: Phase 2
• Start date: November 5, 2018
• Est. completion date: September 27, 2019

Study information

• Verified date: April 2021
• Source: University of Tennessee Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 27, 2019
• Est. primary completion date: September 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Hydrocortisone
Hydrocortisone 50 mg IV Q6h

Locations

Country	Name	City	State
United States	University of Tennessee Medical Center	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Resolution of Shock	Hours for patient to achieve 24 hours vasopressor free	Up to one week