Critical Illness
Conditions
Brief summary
Objective: To compare the pharmacokinetic profiles of intravenous versus subcutaneous route of administration of LMWH for thromboprophylaxis in critically ill patients
Detailed description
The study is a prospective, monocentric, randomized trial. Patients are randomized to the IV route of administration over a 4-hours infusion of nadroparin 3800 IU or to the SC route of administration. Randomization is stratified according to the need for vasopressor or not. Anti-Xa activity is measured at baseline, and at 1, 2, 4, 6, 8, 12 and 24 hours after the administration was started.
Interventions
DRUGNadroparin (intravenous Infusion)
Intravenous route of administration over a 4-hours infusion of nadroparin 3800 IU
DRUGNadroparin (subcutaneous group)
Subcutaneous route of administration of nadroparin 3800 IU
Sponsors
Clinique Saint Pierre Ottignies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults patients \> 18 years old admitted in the ICU, and for whom thromboprophylaxis is indicated
Exclusion criteria
* renal failure determined by glomerular filtration rate (GFR) \< 30 ml/min or need for renal replacement therapy * liver cirrhosis * intravascular disseminated coagulation * contra-indication to thromboprophylaxis for any reason as decided by the treating physician, or indication for therapeutic dosing anticoagulation (recent thrombo-embolic event, atrial fibrillation,…) * patients receiving low dose of vasopressor (norepinephrine \< 0.25 mcg/kg/min) to allow stratification and comparison between patients not on vasopressors and patients with a significant dose of vasopressors (norepinephrine ≥ 0.25 mcg/kg/min)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak anti-Xa activity | Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration | Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trough anti-Xa activity | Trough anti-Xa activity measured 24 hours after start of low molecular weight administration | Trough anti-Xa activity measured 24 hours after start of low molecular weight administration |
| AUC (0-24h) | 0-24 hours | Area under the curve 0-24 hours of anti-Xa activity after start of low molecular weight heparin |
Outcome results
None listed