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

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ClinicalTrials.gov Identifier: NCT03710187
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of Tennessee Medical Center

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. 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.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Combination (Hydrocortisone and Fludrocortisone) Drug: Hydrocortisone Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hydrocortisone and Fludrocortisone Versus Hydrocortisone Alone in Critically Ill Medical Patients With Septic Shock
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019


Arm Intervention/treatment
Experimental: Combination
Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h
Drug: Combination (Hydrocortisone and Fludrocortisone)
Hydrocortisone 50 mg IV Q6h and Fludrocortisone 50 mg PO/PFT Q24h

Active Comparator: Hydrocortisone only
Hydrocortisone 50 mg IV Q6h
Drug: Hydrocortisone
Hydrocortisone 50 mg IV Q6h




Primary Outcome Measures :
  1. Time to resolution of shock [ Time Frame: 24 hours vasopressor free ]
    Number of hours to resolution of shock



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03710187


Contacts
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Contact: Molly Hunt, PharmD 865-305-3517 mehunt@utmck.edu

Locations
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United States, Tennessee
University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Molly Hunt, PharmD    865-305-3517    mdhunt@utmck.edu   
Principal Investigator: Molly E Hunt, PharmD         
Sub-Investigator: Jason Frisbee, DO, PharmD         
Sub-Investigator: Shauna Winters, PharmD         
Sub-Investigator: Tina M Dudney, MD         
Sub-Investigator: Robert E Heidel, PhD         
Sub-Investigator: Paul R Branca, MD         
Sponsors and Collaborators
University of Tennessee Medical Center

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Responsible Party: University of Tennessee Medical Center
ClinicalTrials.gov Identifier: NCT03710187     History of Changes
Other Study ID Numbers: UHS-CC-002
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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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

Additional relevant MeSH terms:
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Shock
Critical Illness
Shock, Septic
Pathologic Processes
Disease Attributes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Fludrocortisone
Anti-Inflammatory Agents