LIPIDS-P Trial Phase I/II Trial

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).

Timeline

Start

2018-08-17

Primary completion

2023-04-26

Completion

2023-04-26

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper Administration of IV lipid emulsion to early sepsis patients with low cholesterol levels did not influence change in cholesterol levels from enrollment to 48 hours. PMID 38488429 ↗

Publications

• Augustin B, Wu D, Black LP, Bertrand A, Sulaiman D, Hopson C, Jacob V, Shavit JA, Hofmaenner DA, Labilloy G, Smith L, Cagmat E, Graim K, Datta S, Reddy ST, Guirgis FW. Multiomic molecular patterns of lipid dysregulation in a subphenotype of sepsis with higher shock incidence and mortality. Crit Care. 2024 Dec 24;28(1):431. doi: 10.1186/s13054-024-05216-3.
• Guirgis FW, Black LP, Henson M, Bertrand A, DeVos E, Ferreira J, Gao H, Wu SS, Leeuwenburgh C, Moldawer L, Moore F, Reddy ST. The Lipid Intensive Drug Therapy for Sepsis Phase II Pilot Clinical Trial. Crit Care Med. 2024 Aug 1;52(8):1183-1193. doi: 10.1097/CCM.0000000000006268. Epub 2024 Mar 15.
• Guirgis FW, Black LP, DeVos E, Henson M, Ferreira J, Miller T, Rosenthal M, Leeuwenburgh C, Kalynych C, Moldawer L, Jones L, Crandall M, Reddy ST, Gao H, Wu S, Moore F. Lipid intensive drug therapy for sepsis pilot: A Bayesian phase I clinical trial. J Am Coll Emerg Physicians Open. 2020 Nov 18;1(6):1332-1340. doi: 10.1002/emp2.12237. eCollection 2020 Dec.
• Guirgis FW, Black LP, Rosenthal MD, Henson M, Ferreira J, Leeuwenburgh C, Kalynych C, Moldawer LL, Miller T, Jones L, Crandall M, Reddy ST, Wu SS, Moore FA. LIPid Intensive Drug therapy for Sepsis Pilot (LIPIDS-P): Phase I/II clinical trial protocol of lipid emulsion therapy for stabilising cholesterol levels in sepsis and septic shock. BMJ Open. 2019 Sep 18;9(9):e029348. doi: 10.1136/bmjopen-2019-029348.

Drugs

Indications