Fondaparinux in Critically Ill Patients With Renal Failure
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Cardiology, Hospital |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 7/11/2015 |
| Start Date: | November 2011 |
| End Date: | November 2013 |
| Contact: | Krista A Wahby, Pharm.D. |
| Email: | khby@dmc.org |
| Phone: | 313-745-2711 |
Use of Fondaparinux in Critically Ill Patients With Renal Failure
The primary objective of this study is to determine whether a dose-adjusted prophylaxis
fondaparinux regimen of 2.5 mg subcutaneously administered q 48 hr in patients with renal
failure achieves peak and trough levels similar to patients with normal renal function, and
protects patients from developing VTE. Our hypothesis is that a dose-adjusted fondaparinux
regimen, which extends the dosing interval from q24 to q48 in patients with estimated
creatinine clearance of < 30 ml/min will be safe and effective.
fondaparinux regimen of 2.5 mg subcutaneously administered q 48 hr in patients with renal
failure achieves peak and trough levels similar to patients with normal renal function, and
protects patients from developing VTE. Our hypothesis is that a dose-adjusted fondaparinux
regimen, which extends the dosing interval from q24 to q48 in patients with estimated
creatinine clearance of < 30 ml/min will be safe and effective.
We will be studying fondaparinux 2.5 mg subcutaneously every 48 hr in three distinct patient
groups: 1) Acute kidney failure without hemodialysis, 2) Acute kidney failure with
intermittent hemodialysis and 3) Acute renal failure with continuous renal replacement
therapy. All patients will be assessed for efficacy of the dose. Efficacy will be assessed
by following clinically for any evidence of VTE, either deep venous thrombosis or pulmonary
embolism. In addition, lower extremity duplex studies will be performed at baseline and at
the end of the study period to assess for DVT.
Secondary objectives will be safety and accumulation. Safety will be determined by
assessment of clinically significant bleeding, defined as a drop in Hgb of > 2gm in 24 hr,
or the need for red blood cell transfusion related to bleeding. Accumulation may occur in
renal failure and will be studied throughout the ICU stay through reevaluation of levels
over time.
groups: 1) Acute kidney failure without hemodialysis, 2) Acute kidney failure with
intermittent hemodialysis and 3) Acute renal failure with continuous renal replacement
therapy. All patients will be assessed for efficacy of the dose. Efficacy will be assessed
by following clinically for any evidence of VTE, either deep venous thrombosis or pulmonary
embolism. In addition, lower extremity duplex studies will be performed at baseline and at
the end of the study period to assess for DVT.
Secondary objectives will be safety and accumulation. Safety will be determined by
assessment of clinically significant bleeding, defined as a drop in Hgb of > 2gm in 24 hr,
or the need for red blood cell transfusion related to bleeding. Accumulation may occur in
renal failure and will be studied throughout the ICU stay through reevaluation of levels
over time.
Inclusion Criteria:
1. Age ≥ 18 years old and ≤ 89 years old
2. Body weight ≥ 50 kg or ≤ 150 kg
3. Estimated creatinine clearance of < 30 mL/min
4. Predicted ICU stay of more than 72 hours.
Exclusion Criteria:
1. Pregnant women
2. Infective Endocarditis
3. Neuraxial anesthesia or spinal puncture
4. Active bleeding
5. Treatment with vitamin K antagonists or therapeutic doses of unfractionated heparin
6. Signs of disseminated intravascular coagulation
7. Severe liver failure (serum bilirubin > 5 mg/dL)
8. Surgery planned within 24 hours of ICU admission
9. Latex allergy
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