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Critical Care

, 3:P154 | Cite as

HES 130/0.4, a new HES specification: pharmacokinetics after multiple infusions of 10% solutions in healthy volunteers

  • F Bepperling
  • J Opitz
  • J Waitzinger
  • G Pabst
  • M Müller
  • JF Baron
Meeting abstract

Keywords

Plasma Concentration Healthy Volunteer Emergency Medicine Close Agreement Peak Plasma 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

An open, one-way, multiple-dose study was performed in twelve (12) healthy male volunteers. Daily infusions of 500 ml of HES (130/0.4) 10% solution were administered within 30 minutes on 10 consecutive days. The plasma and urine HES concentrations were determined repeatedly in the course of the study, up to 72 h after the final infusion.

Both the peak plasma HES concentration and the time course of the plasma concentrations were similar on Day 1 and Day 10 of treatment. There was a marginal increase in the plasma HES concentration 24 h after the infusion, from approximately 0.23 mg/ml on Day 1 to approximately 0.48 mg/ml on Day 10. HES was eliminated from the plasma rapidly with α- and β-half-lives of some 1.2 h to 1.4 h and 21.9 h, respectively. The β-half-life on Day 1 could not be determined with sufficient reliability since the next infusion was given only 24 h later. Although the baseline-corrected AUC0–∞ on Day 1 is thus likely to have been underestimated, the geometric mean of 32.8 h·mg/ml was in fairly close agreement with the result of 35.7 h·mg/ml determined for the AUC0–∞ on Day 10. The results for the urinary recovery of 69% on Day 1 and of 70% on Day 10 agreed very well. It was demonstrated that no clinically relevant accumulation of HES occurred in plasma after multiple-dose administrations of 10 times 500 ml of 10% HES (130/0.4) solutions.
Fig. 1

Plasma Level of HES After Infusion of 500 mL HES (130/0.4) on day 1 and day 10 (mean SD) n = 12.

Copyright information

© Current Science Ltd 1999

Authors and Affiliations

  • F Bepperling
    • 1
  • J Opitz
    • 1
  • J Waitzinger
    • 2
  • G Pabst
    • 2
  • M Müller
    • 2
  • JF Baron
    • 3
  1. 1.FRESENIUS AG, D-61343 Bad HomburgTexas A&M UniversityCollege StationUSA
  2. 2.L.A.B. GmbH & CoNeu-UlmGermany
  3. 3.Départment d'Anesthésie-RéanimationHôpital BroussaisParisFrance

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