The Lipid Intensive Drug Therapy for Sepsis Phase II Pilot Clinical Trial*
Authors' conclusion
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.
Study context
- Population
- Early sepsis patients (first 24 hr) with SOFA ≥4 or shock and low cholesterol (total ≤100 mg/dL or high-density lipoprotein cholesterol (HDL-C) + low-density lipoprotein cholesterol (LDL-C) ≤70 mg/dL), ED or ICUenrolled and randomised
- Participants
- 49 patients
- Comparison
- IV lipid emulsion vs no drug
- Lipid emulsionn = 23
- Controlsn = 24reference
- Primary endpoint
- Change in serum total cholesterol (48 hr − enrollment)
- Follow-up
- 48 hours
Methodological detailsphase II, adaptive, pilot, single academic medical center, Two patients randomized to lipid emulsion withdrawn before drug administration
- Phase II
- Adaptive
- Pilot
- Single academic medical center
- Two patients randomized to lipid emulsion withdrawn before drug administration
Primary result
As reported in the abstract
Mean change in total cholesterol
Lipid emulsion
5
mean · SD 20 · mg/dL
Controls
2
mean · SD 18 · mg/dL
P = 0.62
Further findings
| Outcome | Lipid emulsion | Controls | P value |
|---|---|---|---|
| Mean change in triglyceridesmg/dL | 61 (SD 87) | 20 (SD 70) | P = 0.086 |
| Change in SOFA score · 48 hours | −2 (IQR −3–0) | −2 (IQR −4–-1) | P = 0.46 |
Mean change in HDL-C and LDL-C
- Similar between groups
Original publication
The Lipid Intensive Drug Therapy for Sepsis Phase II Pilot Clinical Trial*. Crit Care Med. Published 15 March 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →