Primary objective: to quantitatively characterize the pharmacokinetics and associated inter-individual and inter-occasion variability of prophylactic nadroparin in critically ill patients.Secondary objectives: To screen and possibly quantify the…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quantitative description of nadroparin pharmacokinetics in critically ill
patients: changes in anti-Xa-time profiles and their possible relationship with
critical illness
Secondary outcome
Niet van toepassing
Background summary
The maintenance of safe and effective anti-coagulation is of utmost importance
for critically ill patients and ineffective treatment can either lead to
bleeding events or thromboembolic events, which have severe clinical
consequences, especially in this fragile group of patients.
LMWHs are routinely administered to patients at the intensive care unit (ICU)
for prophylaxis of venous thromboembolisms, and it has been shown that the use
of these agents is of substantial importance. There is considerable evidence
that LMWH doses should be personalized, but little is known on how this should
be performed in this specific patient group.
This study aims to characterize the PK pharmacokinetics associated variability
across all critically patients being treated with prophylactic LMWH in the ICU.
This characterization may support clinical decision making and design of a
prospective study to establish evidence-based individualized optimal
anti-coagulation therapy in critically ill.
Study objective
Primary objective: to quantitatively characterize the pharmacokinetics and
associated inter-individual and inter-occasion variability of prophylactic
nadroparin in critically ill patients.
Secondary objectives: To screen and possibly quantify the relationship between
renal function, the use of vasopressors, sepsis biomarkers, patient
demographics and CVVH and the pharmacokinetic parameters of nadroparin.
Study design
Cross-sectional observational pilot study
Study burden and risks
This study involves patients who are expected to be mostly incapable of
providing informed consent. However, this observational study cannot be
conducted without their participation. Furthermore, this observational study
has negligible burden and risks, since only 8 additional blood samples (60 mL)
are collected from an already present venous line.
Maatweg 3
Amersfoort 3818TZ
NL
Maatweg 3
Amersfoort 3818TZ
NL
Listed location countries
Age
Inclusion criteria
* The patient is at least 18 years of age.
* The patient is admitted to the intensive care unit.
* The patient is already treated with nadroparin for VTE prophylaxis, or, is eligible for treatment with nadroparin for such reasons.
* The patient already has a catheter to obtain the necessary blood samples.
Exclusion criteria
* Acute and life-threatening complications that require immediate patient treatment, as decided by the intensive care physician.
* The patient is admitted to the ICU for routine post-operative intensive care monitoring
* The patient is treated with a therapeutic dose of nadroparin
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45974.100.13 |