At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 59 enrolled
Drug / intervention
Smoflipiddrug
Likely dose
Not stated in 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.
The LIPid Intensive Drug Therapy for Sepsis ¬Pilot (LIPIDS-P) Phase I/II Trial
In Brief
A Phase 2 clinical trial evaluating Smoflipid for Sepsis, Severe and Septic Shock. Completed, enrolled 59 participants across 3 sites.
Detailed Summary
Briefly, this pilot clinical trial will evaluate preliminary safety and efficacy of the study drug (Smoflipid) at elevating cholesterol levels (primary outcome) in patients with sepsis and moderate organ dysfunction and will also evaluate measures of organ dysfunction, mortality, and biological activity (secondary outcomes).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis, Severe, Septic Shock
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 2018
Enrollment StartAug 2018
Primary CompletionApr 2023
TodayJul 2026
First PostedJan 23, 2018
Enrollment StartAug 17, 2018
Primary CompletionApr 26, 2023
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 8.4 years ago
Interventions
Smoflipiddrug
Administration of lipid injectable emulsion