FindTrial
Sign In

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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03710187
Enrollment
84
Registered
2018-10-18
Start date
2018-11-05
Completion date
2019-09-27
Last updated
2021-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

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.

Interventions

DRUGHydrocortisone

Hydrocortisone 50 mg IV Q6h

Sponsors

University of Tennessee Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to Resolution of ShockUp to one weekHours for patient to achieve 24 hours vasopressor free

Countries

United States

Participant flow

Recruitment details

Adult septic shock patients were recruited from the medical intensive care unit (MICU). Patients were recruited from November 2018 through July 2019.

Pre-assignment details

Patients were randomized to receive HCT 50mg IV Q6h or HCT+FCT 50 mcg PO/PT daily based on admission location within the MICU. Patients were included if age 18 or older, required stress dose steroid therapy, and received fludrocortisone within 24 hours of hydrocortisone if in the combination group.

Participants by arm

ArmCount
Combination
Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h Combination (Hydrocortisone and Fludrocortisone): Hydrocortisone 50 mg IV Q6h and Fludrocortisone 50 mg PO/PFT Q24h
41
Hydrocortisone Only
Hydrocortisone 50 mg IV Q6h Hydrocortisone: Hydrocortisone 50 mg IV Q6h
43
Total84

Baseline characteristics

CharacteristicHydrocortisone OnlyTotalCombination
Age, Categorical
Age
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
Age
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Age
Between 18 and 65 years
43 Participants84 Participants41 Participants
Age, Categorical
Fludrocortisone w/in 24 hrs of hydrocortisone
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
Fludrocortisone w/in 24 hrs of hydrocortisone
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Fludrocortisone w/in 24 hrs of hydrocortisone
Between 18 and 65 years
0 Participants41 Participants41 Participants
Age, Categorical
Required stress dose steroid therapy
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
Required stress dose steroid therapy
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Required stress dose steroid therapy
Between 18 and 65 years
43 Participants84 Participants41 Participants
Race and Ethnicity Not Collected—0 Participants—
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
3 Participants7 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
40 Participants77 Participants37 Participants
Region of Enrollment
United States
43 participants84 participants41 participants
Sex: Female, Male
Female
17 Participants39 Participants22 Participants
Sex: Female, Male
Male
26 Participants45 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 410 / 43
other
Total, other adverse events
0 / 410 / 43
serious
Total, serious adverse events
0 / 410 / 43

Outcome results

Primary

Time to Resolution of Shock

Hours for patient to achieve 24 hours vasopressor free

Time frame: Up to one week

Population: Adult septic shock patients admitted to the MICU. Patients were randomized to an arm of the study based on location within the MICU.

ArmMeasureValue (MEAN)
CombinationTime to Resolution of Shock89 Hours
Hydrocortisone OnlyTime to Resolution of Shock84 Hours

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026