At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 84 enrolled
Drug / intervention
Hydrocortisonedrug
Likely dose
Hydrocortisone 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Hydrocortisone and Fludrocortisone Versus Hydrocortisone Alone in Critically Ill Medical Patients With Septic Shock
In Brief
A Phase 2 clinical trial evaluating Hydrocortisone for Septic Shock. Completed, enrolled 84 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeptic Shock
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartNov 2018
Primary CompletionSep 2019
TodayJul 2026
First PostedOct 18, 2018
Enrollment StartNov 5, 2018
Primary CompletionSep 27, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.7 years ago
Interventions
Hydrocortisonedrug
Hydrocortisone 50 mg IV Q6h