Document Detail

Necessity and risks of arterial blood sampling in healthy volunteer studies.
MedLine Citation:
PMID:  23018527     Owner:  NLM     Status:  MEDLINE    
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.
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
Related Documents :
23707057 - Porcine carotid artery replacement with biodegradable electrospun poly-e-caprolactone v...
20172157 - Modified bentall operation with a novel biologic valved conduit.
21532497 - Conservative management of the pseudoaneurysms of ascending aortic graft: a case of spo...
17126557 - Geometric models of the aortic and pulmonary roots: suggestions for the ross procedure.
23198237 - Vein of galen aneurysmal malformations: an ultrasonographic incidental finding-a case r...
2337497 - Embolisation of a complex coronary arteriovenous fistula in a 6 year old child: the nee...
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    
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Analgesics, Opioid / blood,  pharmacokinetics
Blood Specimen Collection / adverse effects*,  methods
Catheterization, Peripheral / adverse effects*,  methods
Healthy Volunteers
Infusions, Intra-Arterial
Piperidines / blood,  pharmacokinetics
Radial Artery / metabolism*,  ultrasonography
Risk Assessment
Risk Factors
Thrombosis / blood,  etiology*,  surgery,  ultrasonography
Reg. No./Substance:
0/Analgesics, Opioid; 0/Piperidines; P10582JYYK/remifentanil

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

Previous Document:  Impact of the Combined Use of Opioids and Surgical Procedures on Workers' Compensation Cost Among a ...
Next Document:  Pharmacokinetic optimization of antiretroviral therapy in pregnancy.