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

NCT03710187 | Completed Phase 2 Results FDA Drug

• 1 other identifier: UHS-CC-002
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Time to Resolution of Shock

  Hours for patient to achieve 24 hours vasopressor free

  Up to one week

Study Arms (2)

Combination

EXPERIMENTAL

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

Drug: Hydrocortisone

Hydrocortisone only

ACTIVE COMPARATOR

Hydrocortisone 50 mg IV Q6h

Drug: Hydrocortisone

Interventions

Hydrocortisone DRUG

Hydrocortisone 50 mg IV Q6h

Combination; Hydrocortisone only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• University of Tennessee Medical Center: lead

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Results Point of Contact

• Title: Pharm D, Pharmacist Specialist, Critical Care
• Organization: University of Tennessee Medical Center

swinters@utmck.edu

865-305-9134

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 18, 2018
• Study Start: November 5, 2018
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: May 20, 2021
• Results First Posted: May 20, 2021

Record last verified: 2021-04

Locations

US (1)