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

NCT ID: NCT03710187

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-05
• Study Completion Date: 2019-09-27

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.

Conditions

Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination

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

Group Type: EXPERIMENTAL

Hydrocortisone

Intervention Type: DRUG

Hydrocortisone 50 mg IV Q6h

Hydrocortisone only

Hydrocortisone 50 mg IV Q6h

Group Type: ACTIVE_COMPARATOR

Hydrocortisone

Intervention Type: DRUG

Hydrocortisone 50 mg IV Q6h

Interventions

Hydrocortisone

Hydrocortisone 50 mg IV Q6h

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tennessee Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UHS-CC-002

Identifier Type: -

Identifier Source: org_study_id