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

Primary Purpose

Septic Shock

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydrocortisone
Sponsored by
University of Tennessee Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Tennessee Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combination

Hydrocortisone only

Arm Description

Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h

Hydrocortisone 50 mg IV Q6h

Outcomes

Primary Outcome Measures

Time to Resolution of Shock
Hours for patient to achieve 24 hours vasopressor free

Secondary Outcome Measures

Full Information

First Posted
October 15, 2018
Last Updated
April 30, 2021
Sponsor
University of Tennessee Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03710187
Brief Title
HCT+F vs. HCT Alone in Critically Ill Medical Septic Shock Patients
Official Title
Hydrocortisone and Fludrocortisone Versus Hydrocortisone Alone in Critically Ill Medical Patients With Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
September 27, 2019 (Actual)
Study Completion Date
September 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination
Arm Type
Experimental
Arm Description
Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h
Arm Title
Hydrocortisone only
Arm Type
Active Comparator
Arm Description
Hydrocortisone 50 mg IV Q6h
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Intervention Description
Hydrocortisone 50 mg IV Q6h
Primary Outcome Measure Information:
Title
Time to Resolution of Shock
Description
Hours for patient to achieve 24 hours vasopressor free
Time Frame
Up to one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States

12. IPD Sharing Statement

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

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