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Effects of high-dose, intravenous lipid emulsion on laboratory tests in humans: a randomized, placebo-controlled, double-blind, clinical crossover trial

  • Kasper M. Petersen ORCID logo EMAIL logo , Niklas R. Jørgensen , Søren Bøgevig , Tonny S. Petersen , Thomas B. Jensen ORCID logo , Kim P. Dalhoff and Mikkel B. Christensen
Published/Copyright: July 13, 2018
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 56 Issue 12

Abstract

Background

Intravenous lipid emulsion (ILE) is used to treat drug poisonings. The resultant hyperlipemia may affect laboratory tests but the consequences are poorly characterized. In a clinical trial we therefore investigated the effects of ILE on laboratory tests analyzed on common analytical platforms (Roche® cobas 8000 and SYSMEX® flow-cytometry).

Methods

Ten healthy participants each completed 4 trial days (two with ILE and two with placebo). ILE (5.25 mL/kg) was administered from 12.5 to 30 min from baseline. At 0, 30 and 60 min, blood samples were drawn for measurement of 20 analytes. We investigated the effects of ILE on analyte levels and frequencies of exceedance of predefined analyzer hemolysis (H) or lipemia (L)-index cut-offs and test-specific reference change values (RCVs) on ILE-days. If the results were blocked due to exceedance of index values, we manually extracted the results.

Results

Sixteen out of 20 tests were blocked because H- or L-index cut-offs were exceeded on ILE-days. Differences in analyte levels between ILE- and placebo-days above the RCV were observed for aspartate aminotransferase, total calcium, lactate dehydrogenase (LDH), sodium and neutrophils. Mean values outside the normal range after ILE were observed for LDH (219 U/L), sodium (135.3 mmol/L) and total calcium (2.1 mmol/L).

Conclusions

ILE-infusion caused report failure of nearly all laboratory tests performed on a cobas 8000-platform, but it was possible to manually retrieve the results. For most test results – particularly alkaline phosphatase, bilirubin, phosphate and carbamide – the consequences of ILE were marginal, and the effects of ILE were reduced at the 60-min timepoint.

Keywords: analytical interference; intravenous lipid emulsion; lipemia; reference change value; Roche® cobas; SYSMEX®
Corresponding author: Kasper M. Petersen, MD, Department of Clinical Pharmacology, Copenhagen University Hospital Bispebjerg and Frederiksberg, Bispebjerg Bakke 23, 2400 Copenhagen NW, Denmark, Phone: +45 3863 5805

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

  6. Trial registration: ClinicalTrials.gov ID: NCT02924454.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2018-0430).

Received: 2018-04-24
Accepted: 2018-06-20
Published Online: 2018-07-13
Published in Print: 2018-11-27

©2018 Walter de Gruyter GmbH, Berlin/Boston

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Observing an analyzer’s operational life cycle: a useful management tool for clinical laboratories
  4. Reviews
  5. Personalized laboratory medicine: a patient-centered future approach
  6. Circular RNAs: a new class of biomarkers as a rising interest in laboratory medicine
  7. Mini Review
  8. Impact of interactions between drugs and laboratory test results on diagnostic test interpretation – a systematic review
  9. Opinion Paper
  10. Uncertainty in measurement and total error: different roads to the same quality destination?
  11. Guidelines and Recommendations
  12. Joint EFLM-COLABIOCLI Recommendation for venous blood sampling
  13. General Clinical Chemistry and Laboratory Medicine
  14. Evidence for the positive impact of ISO 9001 and ISO 15189 quality systems on laboratory performance – evaluation of immunohaematology external quality assessment results during 19 years in Austria
  15. Effects of high-dose, intravenous lipid emulsion on laboratory tests in humans: a randomized, placebo-controlled, double-blind, clinical crossover trial
  16. Commutability of the certified reference materials for the standardization of β-amyloid 1-42 assay in human cerebrospinal fluid: lessons for tau and β-amyloid 1-40 measurements
  17. Failure rate prediction of equipment: can Weibull distribution be applied to automated hematology analyzers?
  18. Evaluation of serum alkaline phosphatase measurement through the 4-year trueness verification program in China
  19. Increased serum concentrations of soluble ST2 predict mortality after burn injury
  20. The clinical significance of borderline results of the Elia CTD Screen assay
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  41. Congress Abstracts
  42. Congress of Laboratory Medicine and Clinical Chemistry 7th Annual Meeting of the Austrian Society for Laboratory Medicine and Clinical Chemistry (ÖGLMKC)
  43. 50th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC – Laboratory Medicine)
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https://doi.org/10.1515/cclm-2018-0430
Keywords for this article
analytical interference; intravenous lipid emulsion; lipemia; reference change value; Roche® cobas; SYSMEX®

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Observing an analyzer’s operational life cycle: a useful management tool for clinical laboratories
  4. Reviews
  5. Personalized laboratory medicine: a patient-centered future approach
  6. Circular RNAs: a new class of biomarkers as a rising interest in laboratory medicine
  7. Mini Review
  8. Impact of interactions between drugs and laboratory test results on diagnostic test interpretation – a systematic review
  9. Opinion Paper
  10. Uncertainty in measurement and total error: different roads to the same quality destination?
  11. Guidelines and Recommendations
  12. Joint EFLM-COLABIOCLI Recommendation for venous blood sampling
  13. General Clinical Chemistry and Laboratory Medicine
  14. Evidence for the positive impact of ISO 9001 and ISO 15189 quality systems on laboratory performance – evaluation of immunohaematology external quality assessment results during 19 years in Austria
  15. Effects of high-dose, intravenous lipid emulsion on laboratory tests in humans: a randomized, placebo-controlled, double-blind, clinical crossover trial
  16. Commutability of the certified reference materials for the standardization of β-amyloid 1-42 assay in human cerebrospinal fluid: lessons for tau and β-amyloid 1-40 measurements
  17. Failure rate prediction of equipment: can Weibull distribution be applied to automated hematology analyzers?
  18. Evaluation of serum alkaline phosphatase measurement through the 4-year trueness verification program in China
  19. Increased serum concentrations of soluble ST2 predict mortality after burn injury
  20. The clinical significance of borderline results of the Elia CTD Screen assay
  21. Reference Values and Biological Variations
  22. Reference intervals for 33 biochemical analytes in healthy Indian population: C-RIDL IFCC initiative
  23. Cancer Diagnostics
  24. BCL2L12 improves risk stratification and prediction of BFM-chemotherapy response in childhood acute lymphoblastic leukemia
  25. Cardiovascular Diseases
  26. The correlation between glucose fluctuation from self-monitored blood glucose and the major adverse cardiac events in diabetic patients with acute coronary syndrome during a 6-month follow-up by WeChat application
  27. Diabetes
  28. Impact of blood cell counts and volumes on glucose concentration in uncentrifuged serum and lithium-heparin blood tubes
  29. Letters to the Editor
  30. Standard process-oriented workflow introduces pre-analytical error when used in large study sample batches
  31. Comparison of three staining methods in the automated digital cell imaging analyzer Sysmex DI-60
  32. Detection of Plasmodium falciparum using automated digital cell morphology analyzer Sysmex DI-60
  33. Serum ischemia-modified albumin concentration may reflect long-term hypoxia in chronic respiratory disease: a pilot study
  34. Wet absorptive microsampling at home for HbA1c monitoring in diabetic children
  35. Serum endocan levels in patients with chronic obstructive pulmonary disease: a potential role in the evaluation of susceptibility to exacerbation
  36. Analytical and clinical validation of the new Roche Elecsys Vitamin D Total II assay
  37. Analytical validation of two second generation thyroglobulin immunoassays (Roche and Thermo Fisher)
  38. Omission of preservatives during 24-h of urine collection for the analysis of fractionated metanephrines enhance patient convenience
  39. Transient monoclonal gammopathy in a 2-year-old child with combined viral and bacterial infection
  40. Nephelometric assay of urine free light chains: an alternative and early clinical test for Bence-Jones protein quantification
  41. Congress Abstracts
  42. Congress of Laboratory Medicine and Clinical Chemistry 7th Annual Meeting of the Austrian Society for Laboratory Medicine and Clinical Chemistry (ÖGLMKC)
  43. 50th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC – Laboratory Medicine)
  44. Revolution drives Evolution – from measuring to understanding: Annual meeting of Swiss Society of Clinical Chemistry (SSCC) in Bern, November 15-16 2018
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