CAPER Unit Awarded Grant to Study New Lipid Formulation

Duke Anesthesiology’s Critical Care and Perioperative Population Health Research (CAPER) Unit

Duke Anesthesiology’s Paul Wischmeyer, MD, EDIC and the Critical Care and Perioperative Population Health Research (CAPER) Unit have been awarded a $130,000 grant for their project, titled “Impact of SMOFlipid on Clinical Outcomes Among Patients Receiving Parenteral Nutrition: An Interrupted Time Series Analysis.” The researchers will use the funding to study the effect of a newly-implemented advanced parenteral nutrition lipid on clinical outcomes versus previously used Omega-6 soy lipid.

The grant was awarded by Fresenius-Kabi Inc. Wischmeyer serves as the principal investigator of the grant; co-investigators include Drs. Vijay Krishnamoorthy, Karthik Raghunathan, Tetsu Ohnuma, Krista Haines (Duke Surgery), and Surgical Intensive Care Unit fellow, Dr. Osamudiamen Obanor.

The research team will examine the hypothesized benefits of a new IV nutrition lipid used for total parenteral nutrition (TPN) on clinical outcomes in Duke’s patients since Duke adopted the new lipid in 2017. Duke was among the first academic health centers in the nation to widely adopt the new lipid as it was only FDA approved in 2017. Wischmeyer notes that parenteral nutrition has been traditionally thought to potentially lead to increased infection risk. However, he says recent large randomized trials in Intensive Care Unit (ICU) patients in high-impact journals (New England Journal of Medicine, Lancet, JAMA) have shown there is no longer any association of TPN with infectious risk, even in ICU patients; but it is unclear what factors have reduced this risk.

One hypothesis the newly-funded study will explore is that newer lipid formulations containing fish oil, olive oil and a “healthier” fat mix reduces infection versus previously utilized Omega-6 lipids that have been used in the US for more than 40 years. This new trial will look at all Duke patients from neonates to adults who received new, healthier (SMOF) lipid formulation at Duke. And, using the unique talents of the CAPER Unit, they’ll compare similar patients from the period immediately prior to the new lipids introduction looking for differences in infection, length of stay, liver injury, and other clinical outcomes.

Results of this study are expected to provide unique insight to specific contribution of new, healthier lipid formulations to TPN safety and improved clinical outcomes. This could also lead to larger clinical trials or large health outcome database research funding opportunities to explore this question and other methods to improve outcomes with TPN.

“The US has a unique opportunity to finally utilize a safe and more optimally-balanced lipid formulation that has shown preliminary data to reduce infection, length of stay and improve clinical outcomes,” says Wischmeyer, professor of anesthesiology and associate vice chair for clinical research. “This study with our Duke Anesthesiology CAPER Unit provides a unique ‘real-world’ clinical care research opportunity to evaluate the contribution of this long-awaited new generation of lipid formulations to improve outcomes.”

Stacey HiltonCAPER Unit Awarded Grant to Study New Lipid Formulation