ArticleJournal of the American College of Emergency Physicians open2020
Lipid intensive drug therapy for sepsis pilot: A Bayesian phase I clinical trial.
Article in Journal of the American College of Emergency Physicians open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03405870 (The LIPid Intensive Drug Therapy for Sepsis ¬Pilot), which is not on this map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The LIPid Intensive Drug Therapy for Sepsis ¬Pilot (LIPIDS-P) Phase I/II Trial
Who cites it
5 citing papers in PubMed, 12 citations in OpenAlex.
- Article
- Multiomic molecular patterns of lipid dysregulation in a subphenotype of sepsis with higher shock incidence and mortality.Critical care (London, England) · 2024Article
- Association Between Hypocholesterolemia and Mortality in Critically Ill Patients With Sepsis: A Systematic Review and Meta-Analysis.Critical care explorations · 2023Review
- Lipid and Lipoprotein Dysregulation in Sepsis: Clinical and Mechanistic Insights into Chronic Critical Illness.Journal of clinical medicine · 2021Review
- Lipid intensive drug therapy for sepsis pilot: A Bayesian phase I clinical trial.Journal of the American College of Emergency Physicians open · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesCholesterol may be protective in sepsis. Patients with early sepsis may have critically low cholesterol levels that are associated with poor outcomes. The study objective was to test the safety of a fish oil-containing lipid injectable emulsion for stabilizing early cholesterol levels in sepsis.
methodsPhase I Bayesian optimal interval design trial of adult patients with septic shock (Sequential Organ Failure Assessment score ≥4 or vasopressor dependence). Using sequential dose escalation, participants received 2 doses of 1.0 to 1.6 g/kg of lipid emulsion (Smoflipid 20% lipid emulsion) within 48 hours of enrollment. Cholesterol levels, function, and organ failure were assessed serially during the first 7 days of hospital admission. MEASUREMENTS AND MAIN
resultsA total of 10 patients with septic shock were enrolled. One patient withdrew for social reasons. Another patient had an unrelated medical complication and received 1 drug dose. Of 9 patients, mean age was 58 years (SD 16), median Sequential Organ Failure Assessment was 8, and 28-day mortality was 30%. No serious adverse events related to lipid infusion occurred. The six occurrences of non-serious adverse events possibly related to lipid infusion included hyperglycemia (1), elevated triglycerides (3), anemia (1), and vascular access redness/pain (1) for all doses. The mean change in total cholesterol levels from enrollment was -7 (SD 16.6) at 48 hours and 14 (SD 25.2) at 7 days.
conclusionsFish oil-containing lipid emulsion administration during early septic shock was safe. Further studies are needed to assess effects on cholesterol levels, function, and organ failure. CLINICAL
trial registrationNCT03405870.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.