Influence of infusion method on gemcitabine pharmacokinetics: a controlled randomized multicenter trial

Simon, Nicolas; Romano, O.; Michel, Pierre; Pinçon, Claire; Vasseur, Michèle; Lemahieu, Nicole; Barthélémy, Christine; Hebbar, Mohamed; Décaudin, Bertrand; Odou, Pascal

doi:10.1007/s00280-015-2819-3

Cited by 4 publications

(4 citation statements)

References 23 publications

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“…Four studies 11 , 24 – 26 examined the flow rate accuracy of infusion pumps using a simulation design. Other studies included one cohort design, 22 , 27 one cross-sectional design 23 and one randomised controlled trial. 20 The infusion devices examined across the included studies were elastomeric, volumetric, peristaltic, pain/ambulatory, flow regulators, syringes and gravity-led infusion sets.…”

Section: Resultsmentioning

confidence: 99%

“…Carleton et al 23 did well in reporting outcomes and potential confounding variables that could affect the results of their study, the article had problems in the 'random sequence generation', 'allocation concealment', 'blinding of participants or personnel' and 'blinding of outcome assessment'. Simon et al 27 had problems in the 'random sequence generation' and 'allocation TherapeuTic advances in drug safety concealment' domains. Studies that have utilised a simulation design are difficult to rely upon because of their difficulty predicting responses in real-life contexts.…”

Section: Quality and Risk Of Biasmentioning

confidence: 99%

“…The quality of the evidence was examined according to the design of the studies due to the heterogeneity in the designs of the included studies. The Robvis ‘Generic’ tool showed that two studies had a high risk of bias 23 , 27 (see Figure 2 below). Carleton et al 23 did well in reporting outcomes and potential confounding variables that could affect the results of their study, the article had problems in the ‘random sequence generation’, ‘allocation concealment’, ‘blinding of participants or personnel’ and ‘blinding of outcome assessment’.…”

Section: Quality and Risk Of Biasmentioning

confidence: 99%

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Flow rate accuracy of infusion devices within healthcare settings: a systematic review

Atanda,

West,

Stables

et al. 2023

Therapeutic Advances in Drug Safety

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Background: One in five patients admitted to the hospital treated with intravenous (IV) fluid therapy suffer complications due to inappropriate administration. Errors have been reported in 13–84% of the preparation and administration of IV medications. The safe delivery of IV fluids requires precise rate administration. Objectives: This systematic review aims to determine the accuracy of infusion sets and devices and examine the factors that affect the flow rate accuracy of devices. Data Sources and Methods: Six databases (CINAHL, MEDLINE PubMed, EMBASE, Web of Science and Cochrane Database of systematic reviews) were systematically searched. Search terms included infusion pumps, infusion devices, flow rate accuracy, fluid administration rate, gravity-led infusion set and fluid balance. Studies were included if they examined infusion devices’ flow rate accuracy and drop rates for fluids or non-oncological drugs. Findings were tabulated and synthesised qualitatively. The quality of the studies was examined based on the design of the studies due to their heterogeneity. Results: Eight studies were included: Four studies were conducted on human subjects in the hospital environment; studies recruited 182 participants between the ages of 18 and 94 years. Two studies examined flow rate accuracy in recruited patients across 509 observations and 2387 drip hours. No trials prospectively assessed the accuracy of infusion pumps in the clinical domain, and no studies were reported on patient safety outcomes. Four studies examined the impact of mechanical and physiological factors on the flow rate accuracies of infusion devices. Height and back pressure simulated vibrating conditions, the viscosity of IV fluid and the positions of patients were reported to have a significant impact on infusion volume and flow rates of infusion devices. Additionally, giving sets that vary from the manufacturer’s specifications are reported to increase error percent by 10–20%. Conclusion: Infusion devices are an important source of error in administering IV fluids. Yet, there needs to be more prospective trial data to support their clinical accuracy and the impact on patient outcomes. Future flow variability and accuracy studies should capture their impact on patient safety and clinical outcomes.

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Section: Resultsmentioning

confidence: 99%

Section: Quality and Risk Of Biasmentioning

confidence: 99%

Section: Quality and Risk Of Biasmentioning

confidence: 99%

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Flow rate accuracy of infusion devices within healthcare settings: a systematic review

Atanda,

West,

Stables

et al. 2023

Therapeutic Advances in Drug Safety

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“…Cytidine deaminase (CDA) catalyses the inactivation of gemcitabine to 2′,2′-difluoro-2′-deoxyuridine (dFdU) ( Gusella et al, 2011 ; Simon et al, 2015 ; Cohen et al, 2019 ). CDA expression and activity in peripheral blood ( Bowen et al, 2009 ) have been attributed both to lack of effect and increased toxicity of gemcitabine ( Sugiyama et al, 2007 ; Ciccolini et al, 2010 ; Gusella et al, 2011 ).…”

Section: Introductionmentioning

confidence: 99%

Intracellular Cytidine Deaminase Regulates Gemcitabine Metabolism in Pancreatic Cancer Cell Lines

et al. 2019

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Cytidine deaminase (CDA) is a determinant of in vivo gemcitabine elimination kinetics and cellular toxicity. The impact of CDA activity in pancreatic ductal adenocarcinoma (PDAC) cell lines has not been elucidated. We hypothesized that CDA regulates gemcitabine flux through its inactivation and activation pathways in PDAC cell lines. Three PDAC cell lines (BxPC-3, MIA PaCa-2, and PANC-1) were incubated with 10 or 100 mM gemcitabine for 60 minutes or 24 hours, with or without tetrahydrouridine, a CDA inhibitor. Extracellular inactive gemcitabine metabolite (dFdU) and intracellular active metabolite (dFdCTP) were quantified with liquid chromatography tandem mass spectrometry. Cellular expression of CDA was assessed with real-time PCR and Western blot. Gemcitabine conversion to dFdU was extensive in BxPC-3 and low in MIA PaCa-2 and PANC-1, in accordance with their respective CDA expression levels. CDA inhibition was associated with low or undetectable dFdU in all three cell lines. After 24 hours gemcitabine incubation, dFdCTP was highest in MIA PaCa-2 and lowest in BxPC-3. CDA inhibition resulted in a profound dFdCTP increase in BxPC-3 but not in MIA PaCa-2 or PANC-1. dFdCTP concentrations were not higher after exposure to 100 versus 10 mM gemcitabine when CDA activities were low (MIA PaCa-2 and PANC-1) or inhibited (BxPC-3). The results suggest a regulatory role of CDA for gemcitabine activation in PDAC cells but within limits related to the capacity in the activation pathway in the cell lines. SIGNIFICANCE STATEMENT The importance of cytidine deaminase (CDA) for cellular gemcitabine toxicity, linking a lower activity to higher toxicity, is well described. An underlying assumption is that CDA, by inactivating gemcitabine, limits the amount available for the intracellular activation pathway. Our study is the first to illustrate this regulatory role of CDA in pancreatic ductal adenocarcinoma cell lines by quantifying intracellular and extracellular gemcitabine metabolite concentrations.

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Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma

Stephenson

Cao

Taggart

et al. 2021

European Journal of Medicinal Chemistry

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Influence of infusion method on gemcitabine pharmacokinetics: a controlled randomized multicenter trial

Cited by 4 publications

References 23 publications

Flow rate accuracy of infusion devices within healthcare settings: a systematic review

Flow rate accuracy of infusion devices within healthcare settings: a systematic review

Intracellular Cytidine Deaminase Regulates Gemcitabine Metabolism in Pancreatic Cancer Cell Lines

Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma

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