HCT+F vs. HCT Alone in Critically Ill Medical Septic Shock Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Hospital, Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2019 |
| Start Date: | November 5, 2018 |
| End Date: | July 31, 2019 |
| Contact: | Molly Hunt, PharmD |
| Email: | mehunt@utmck.edu |
| Phone: | 865-305-3517 |
Hydrocortisone and Fludrocortisone Versus Hydrocortisone Alone in Critically Ill Medical Patients With Septic Shock
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.
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.
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
We found this trial at
1
site
Knoxville, Tennessee 37920
Principal Investigator: Molly E Hunt, PharmD
Phone: 865-305-3517
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