External validation and updating of the infusion rate individualization of soybean oil-based intravenous lipid emulsion: A descriptive cohort study

Keizo Fukushima; Kenji Omura; Satoshi Goshi; Azusa Futatsugi; Yoriyuki Takamori; Takahiro Sasamoto; Takae Tsujimoto; Keiji Iriyama; Nobuyuki Sugioka

doi:10.1002/jpen.2636

External validation and updating of the infusion rate individualization of soybean oil-based intravenous lipid emulsion: A descriptive cohort study

JPEN J Parenter Enteral Nutr. 2024 May 11. doi: 10.1002/jpen.2636. Online ahead of print.

Authors

Keizo Fukushima¹, Kenji Omura², Satoshi Goshi³, Azusa Futatsugi¹, Yoriyuki Takamori⁴, Takahiro Sasamoto⁵, Takae Tsujimoto⁶, Keiji Iriyama⁷, Nobuyuki Sugioka¹

Affiliations

¹ Department of Clinical Pharmacokinetics, Faculty of Pharmaceutical Sciences, Kobe Gakuin University, Kobe, Japan.
² Department of Surgery, Ageo Central General Hospital, Saitama, Japan.
³ Department of Gastroenterology and Hepatology, Joetsu General Hospital, Niigata, Japan.
⁴ Department of Hepatology, Ageo Central General Hospital, Saitama, Japan.
⁵ Department of Gastroenterology, Ageo Central General Hospital, Saitama, Japan.
⁶ Department of Pathophysiology, Faculty of Pharmaceutical Sciences, Kobe Gakuin University, Kobe, Japan.
⁷ Department of Surgery, Nagashima Central Hospital, Mie, Japan.

PMID: 38734877
DOI: 10.1002/jpen.2636

Abstract

Background: Safe and efficient provision of intravenous lipid emulsion (ILE) requires a strategy to individualize infusion rates. Estimating the maximum acceptable infusion rate (MaxInfRate) of soybean oil-based ILE (SO-ILE) in individuals by using a triglyceride (TG) kinetic model was reported to be feasible. In this study, we aimed to externally validate and, if needed, update the MaxInfRate estimation.

Methods: The maximum TG concentration (TG_max) in patients receiving SO-ILE at MaxInfRate was evaluated to determine if it met the definition of being <400 mg/dl for 90th percentile of patients. The TG kinetic model was evaluated through prediction performance checks and was subsequently updated using the data set of both the previous model development and present validation studies.

Results: Out of 83 patients, 74 had TG_max <400 mg/dl, corresponding to a probability of 89.2% (95% CI, 81.9%-95.2%), and the 90th percentile of TG_max was 400 mg/dl (95% CI, 328-490 mg/dl), closely aligned with the theoretical values. However, the individual TG_max values were biased by the infusion rate because the covariate effects were overestimated in the TG kinetic model, requiring a minor revision. The updated MaxInfRate with the combined data set showed unbiased and more accurate predictions.

Conclusion: The MaxInfRate was validated in external inpatients and updated with all available data. MaxInfRate estimation for individuals could be an option for the safe and efficient provision of SO-ILE.

Keywords: individualization; intravenous lipid emulsion; model‐informed precision dosing; triglyceride.