Lipid globule size in total nutrient admixtures prepared in three-chamber plastic bags

Driscoll, David F.; Thoma, Andrea; Franke, R. P.; Klütsch, Karsten; Nehne, Jörg; Bistrian, Bruce R.

doi:10.2146/ajhp080164

Cited by 29 publications

(37 citation statements)

References 16 publications

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“…IVFE is particularly susceptible to contamination or instability because of these unique formulation characteristics. 60,68,[176][177][178][179][188][189][190][191][192][193][194][195][196] Several factors contribute to risk of negative clinical outcomes due to compromised IVFE sterility or stability including effect of the container material, length of infusion, length of time between infusion set change, effect of infusion from source container such as infusion from the original container, infusion as an IVFE admixture, and infusion of IVFE transferred to a secondary container. 60,68,[176][177][178][179]188,[194][195][196] The BUD for unspiked IVFE in original packaging is dictated by the manufacturer's expiration date (Table 19).…”

Section: Recommendationmentioning

confidence: 99%

“…60,68,[176][177][178][179]188,[194][195][196] In addition, the Centers for Disease Control and Prevention provides no guidance on infectious risk for BUD of IVFE transferred to a secondary container. Instead, the most recent statement recommends IV tubing replacement every 24 hours for both IVFE infused separately or when given as part of a TNA.…”

Section: Table 20 (Continued)mentioning

confidence: 99%

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A.S.P.E.N. Clinical Guidelines

Boullata

Gilbert

Sacks

et al. 2014

J Parenter Enteral Nutr

263

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Background: Parenteral nutrition (PN) is a high-alert medication available for patient care within a complex clinical process. Beyond application of best practice recommendations to guide safe use and optimize clinical outcome, several issues are better addressed through evidence-based policies, procedures, and practices. This document provides evidence-based guidance for clinical practices involving PN prescribing, order review, and preparation. Method: A systematic review of the best available evidence was used by an expert work group to answer a series of questions about PN prescribing, order review, compounding, labeling, and dispensing. Concepts from the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) format were applied as appropriate. The specific clinical guideline recommendations were developed using consensus prior to review and approval by the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. The following questions were addressed: (1) Does education of prescribers improve PN ordering? (2) What is the maximum safe osmolarity of PN admixtures intended for peripheral vein administration? (3) What are the appropriate calcium intake and calciumphosphate ratios in PN for optimal neonatal bone mineralization? (4) What are the clinical advantages or disadvantages of commercially available premade ("premixed") multichambered PN formulations compared with traditional/customized PN formulations? (5) What are the clinical (infection, catheter occlusion) advantages or disadvantages of 2-in-1 compared with 3-in-1 PN admixtures? (6) What macronutrient dosing limits are expected to provide for the most stable 3-in-1 admixtures? (7) What are the most appropriate recommendations for optimizing calcium (gluconate) and (Na-or K-) phosphate compatibility in PN admixtures? (8) What micronutrient contamination is present in parenteral stock solutions currently used to compound PN admixtures? (9) Is it safe to use the PN admixture as a vehicle for non-nutrient medication delivery? (10) Should heparin be included in the PN admixture to reduce the risk of central vein thrombosis? (11) What methods of repackaging intravenous fat emulsion (IVFE) into smaller patient-specific volumes are safe? (12) What beyond-use date should be used for (a) IVFE dispensed for separate infusion in the original container and (b) repackaged IVFE? (JPEN J Parenter Enteral Nutr. 2014;38:334-377)

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Section: Recommendationmentioning

confidence: 99%

Section: Table 20 (Continued)mentioning

confidence: 99%

A.S.P.E.N. Clinical Guidelines

Boullata

Gilbert

Sacks

et al. 2014

J Parenter Enteral Nutr

263

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show abstract

“…Method II assesses the large-diameter tail, expressed as the volume-weighted PFAT5. The globule size parameters are set based on blood vessel physiology and anatomy, as well as evidence suggesting particles greater than 5 micrometers are large enough to occlude small capillaries and risk of pulmonary embolism [12]. Although this study utilized non-optical method for counting and sizing particles, future studies should compare the results of this study with analysis of globule size using light-scattering, light obscuration or extinction techniques.…”

Section: Discussionmentioning

confidence: 99%

Physiochemical Stability of Intravenous Fat Emulsion in Combination with Medications Used for Resuscitation

Cocchio

Geib²,

Rynn³

2013

SOJPPS

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“…The negatively charged surface (phosphate moiety) prevents the coalescence of the lipid globules [2]. A pH below 5.0 favours lipid instabilities [23].…”

Section: Because the Chemical Analysis With Lc-ms/msmentioning

confidence: 99%

Physicochemical stability and compatibility testing of levetiracetam in all-in-one parenteral nutrition admixtures in daily practice

Aeberhard

Saxer

Huber

et al. 2017

European Journal of Pharmaceutical Sciences

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Lipid globule size in total nutrient admixtures prepared in three-chamber plastic bags

Abstract: Injectable lipid emulsions provided in 3CP bags that did not meet the globule-size limits of USP chapter 729 produced coarser TNA formulations than emulsions that met the USP limits.

Cited by 29 publications

References 16 publications

A.S.P.E.N. Clinical Guidelines

A.S.P.E.N. Clinical Guidelines

Physiochemical Stability of Intravenous Fat Emulsion in Combination with Medications Used for Resuscitation

Physicochemical stability and compatibility testing of levetiracetam in all-in-one parenteral nutrition admixtures in daily practice

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