Trial Outcomes & Findings for HCT+F vs. HCT Alone in Critically Ill Medical Septic Shock Patients (NCT NCT03710187)
NCT ID: NCT03710187
Last Updated: 2021-05-20
Results Overview
Hours for patient to achieve 24 hours vasopressor free
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
Up to one week
Results posted on
2021-05-20
Participant Flow
Adult septic shock patients were recruited from the medical intensive care unit (MICU). Patients were recruited from November 2018 through July 2019.
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.
Participant milestones
| Measure |
Combination
Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h
|
Hydrocortisone Only
Hydrocortisone 50 mg IV Q6h
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
43
|
|
Overall Study
COMPLETED
|
41
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants in hydrocortisone only arm did not receive Fludrocortisone.
Baseline characteristics by cohort
| Measure |
Combination
n=41 Participants
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
|
Hydrocortisone Only
n=43 Participants
Hydrocortisone 50 mg IV Q6h
Hydrocortisone: Hydrocortisone 50 mg IV Q6h
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Age · <=18 years
|
0 Participants
n=41 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
0 Participants
n=43 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
0 Participants
n=84 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
|
Age, Categorical
Age · Between 18 and 65 years
|
41 Participants
n=41 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
43 Participants
n=43 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
84 Participants
n=84 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
|
Age, Categorical
Age · >=65 years
|
0 Participants
n=41 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
0 Participants
n=43 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
0 Participants
n=84 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
|
Age, Categorical
Required stress dose steroid therapy · <=18 years
|
0 Participants
n=41 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
0 Participants
n=43 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
0 Participants
n=84 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
|
Age, Categorical
Required stress dose steroid therapy · Between 18 and 65 years
|
41 Participants
n=41 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
43 Participants
n=43 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
84 Participants
n=84 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
|
Age, Categorical
Required stress dose steroid therapy · >=65 years
|
0 Participants
n=41 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
0 Participants
n=43 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
0 Participants
n=84 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
|
Age, Categorical
Fludrocortisone w/in 24 hrs of hydrocortisone · <=18 years
|
0 Participants
n=41 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
0 Participants
Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
0 Participants
n=41 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
|
Age, Categorical
Fludrocortisone w/in 24 hrs of hydrocortisone · Between 18 and 65 years
|
41 Participants
n=41 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
0 Participants
Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
41 Participants
n=41 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
|
Age, Categorical
Fludrocortisone w/in 24 hrs of hydrocortisone · >=65 years
|
0 Participants
n=41 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
0 Participants
Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
0 Participants
n=41 Participants • Participants in hydrocortisone only arm did not receive Fludrocortisone.
|
|
Sex: Female, Male
Female
|
22 Participants
n=41 Participants
|
17 Participants
n=43 Participants
|
39 Participants
n=84 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=41 Participants
|
26 Participants
n=43 Participants
|
45 Participants
n=84 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=84 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=84 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=84 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=41 Participants
|
3 Participants
n=43 Participants
|
7 Participants
n=84 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=41 Participants
|
40 Participants
n=43 Participants
|
77 Participants
n=84 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=84 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=84 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
41 participants
n=41 Participants
|
43 participants
n=43 Participants
|
84 participants
n=84 Participants
|
PRIMARY outcome
Timeframe: Up to one weekPopulation: Adult septic shock patients admitted to the MICU. Patients were randomized to an arm of the study based on location within the MICU.
Hours for patient to achieve 24 hours vasopressor free
Outcome measures
| Measure |
Combination
n=41 Participants
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
|
Hydrocortisone Only
n=43 Participants
Hydrocortisone 50 mg IV Q6h
Hydrocortisone: Hydrocortisone 50 mg IV Q6h
|
|---|---|---|
|
Time to Resolution of Shock
|
89 Hours
Interval 60.0 to 132.0
|
84 Hours
Interval 56.0 to 125.0
|
Adverse Events
Combination
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hydrocortisone Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Pharm D, Pharmacist Specialist, Critical Care
University of Tennessee Medical Center
Phone: 865-305-9134
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place