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ID
Source
Brief title
Health condition
Critically ill patients
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence of inadequate estimated peak anti-factor-Xa levels after therapeutic nadroparin in a general intensive care unit population
Secondary outcome
To evaluate the pharmacokinetics of therapeutic nadroparin in a general intensive care unit population by measuring anti-factor Xa levels.
Background summary
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.
Study objective
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.
Study design
Measurements will take place up to 12 hours after a 2-daily administration and 24 hours after a 1-daily administration of nadroparin.
Intervention
NA
Inclusion criteria
(1) Admitted to the Intensive Care with nadroparin in therapeutic dose (1-daily or 2-daily)
(2) Age ≥ 18 years
Exclusion criteria
(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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8205 |
| Other | Regionale Toetsingscommissie Patiëntgebonden Onderzoek : RTPO 1088 |