Document Detail


Necessity and risks of arterial blood sampling in healthy volunteer studies.
MedLine Citation:
PMID:  23018527     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Arterial blood sampling is necessary when drugs such as the fast-acting opioid analgesic remifentanil exhibit relevant differences between arterial and venous blood concentrations. Arterial cannulation is generally considered to be clinically safe and has thus become a standard procedure in pharmacokinetic-pharmacodynamic assessments. However, rare cases of arterial occlusions have to be considered in risk-benefit assessments of arterial sampling in pharmacokinetic studies, especially when including healthy volunteers. In an actual case, arterial occlusion requiring surgical repair was caused by a factor V Leiden thrombophilia associated genetic variant F5 1691G>A (rs6025) and aggravated by a hypoplastic radial artery. Neither risk factor had been identified prior to enrolment by routine laboratory tests such as the prothrombin time (international normalized ratio), partial thromboplastin time and the clinical Allen's test of arterial function. Re-assessment of the necessity of arterial sampling showed that none of the potential alternatives, target concentrations of computerized infusions or venous concentrations during non-steady-state and steady-state conditions could provide the arterial concentrations. Relying on venous concentrations may result in erroneous pharmacodynamic parameters. Accurate pharmacokinetic-pharmacodynamic studies relying on precisely measured blood concentrations require serial sampling techniques during both steady-state and non-steady-state conditions. However, as illustrated by the presented case, incidents involving the generally safe procedure of arterial sampling are possible, although rare. To further minimize the risks, screening of subjects for prothrombotic risks and careful assessment of the suitability of the artery should be considered in pharmacokinetic studies requiring arterial cannulation.
Authors:
Bruno Georg Oertel; Johannes Vermehren; Michael Zimmermann; Thomas Tao Huynh; Alexandra Doehring; Nerea Ferreiros; Stephan Senzel; Thomas Schmitz-Rixen; Matthias Erbe; Gerd Geisslinger; Sebastian Harder; Martin S Angst; Jörn Lötsch
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Publication Detail:
Type:  Case Reports; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Clinical pharmacokinetics     Volume:  51     ISSN:  0312-5963     ISO Abbreviation:  Clin Pharmacokinet     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-09-28     Completed Date:  2013-02-14     Revised Date:  2013-12-10    
Medline Journal Info:
Nlm Unique ID:  7606849     Medline TA:  Clin Pharmacokinet     Country:  New Zealand    
Other Details:
Languages:  eng     Pagination:  629-38     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Adult
Analgesics, Opioid / blood,  pharmacokinetics
Blood Specimen Collection / adverse effects*,  methods
Catheterization, Peripheral / adverse effects*,  methods
Healthy Volunteers
Humans
Infusions, Intra-Arterial
Male
Piperidines / blood,  pharmacokinetics
Radial Artery / metabolism*,  ultrasonography
Risk Assessment
Risk Factors
Thrombectomy
Thrombosis / blood,  etiology*,  surgery,  ultrasonography
Chemical
Reg. No./Substance:
0/Analgesics, Opioid; 0/Piperidines; P10582JYYK/remifentanil

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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