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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Hydrocortisone and Fludrocortisone Versus Hydrocortisone Alone in Critically Ill Medical Patients With Septic Shock

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: Hydrocortisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination<br>Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h | Drug: Hydrocortisone<br>* Hydrocortisone 50 mg IV Q6h<br>|
| Active Comparator: Hydrocortisone only<br>Hydrocortisone 50 mg IV Q6h | Drug: Hydrocortisone<br>* Hydrocortisone 50 mg IV Q6h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Resolution of Shock | Hours for patient to achieve 24 hours vasopressor free | Up to one week |