We hypothesize that in critically ill patients, measuring the anti-factor-Xa randomly in a 3 to 5 hours timeframe, may introduce a significant variation in the measured anti-factor-Xa and can seriously underestimate the real peak anti-factor-Xa.
Verkorte titel
Health condition
Critically ill patients
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The incidence of inadequate estimated peak anti-factor-Xa levels after therapeutic nadroparin in a general intensive care unit population
Achtergrond van het onderzoek
Monitoring the peak anti-factor-Xa is advised in the treatment of therapeutic nadroparin in cases of less predictable pharmacokinetic properties such as renal insufficiency, obese patients and pregnant woman. Target ranges of this peak anti-factor-Xa are measured 3 to 5 hours after the s.c. injection of nadroparin. Based on the literature the time to reach the peak anti-factor-Xa of nadroparin (t-max) can be expected also before and after this 3 to 5 hour time-window. Critically ill patients experience divers physiological changes and may use medication that can significantly affect the pharmacokinetics of subcutaneous administered nadroparin. Although the impact of this variable t-max on the height of the measured anti-factor-Xa is not known, the measured levels are clinically used for dosage adjustments of the nadroparin in the treatment of venous thromboembolism and prevention of stroke in atrial fibrillation. In this study we will investigate the reliability of the 3 - 5 hour sampling-window of anti-Xa for changing dosages of therapeutic nadroparin in critically ill patients.
Doel van het onderzoek
We hypothesize that in critically ill patients, measuring the anti-factor-Xa randomly in a 3 to 5 hours timeframe, may introduce a significant variation in the measured anti-factor-Xa and can seriously underestimate the real peak anti-factor-Xa.
Onderzoeksopzet
Measurements will take place up to 12 hours after a 2-daily administration and 24 hours after a 1-daily administration of nadroparin.
Onderzoeksproduct en/of interventie
NA
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
(1) Admitted to the Intensive Care with nadroparin in therapeutic dose (1-daily or 2-daily)
(2) Age ≥ 18 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
(1) Pregnancy
(2) Requiring hemodialysis (HD) or Continuous Veno-Venous Hemofiltration (CVVH)
(3) Treated with a DOAC, unfractionated heparin, another LMWH, or a GP IIb / IIIa receptor antagonist 72hours to 0 hours before the first bloodsample is drawn or during bloodsampling.
(4) Participation in another study
Opzet
Deelname
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