Pharmacokinetic Assessment of Peramivir in Hospitalized Adults Undergoing Continuous Renal Replacement Therapy
| Status: | Withdrawn |
|---|---|
| Conditions: | Influenza, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | February 2010 |
| End Date: | February 2011 |
Pharmacokinetics for peramivir have not been well characterized in patients undergoing
continuous renal replacement therapy CRRT - either Continuous veno-venous hemofiltration
(CVVH) +/- dialysis (CVVHD). CRRT is commonly utilized in the hospital setting for patients
with acute kidney injury for metabolic correction, slow continuous fluid removal, and to
maintain hemodynamic stability. CRRT commonly alters drug disposition and clearance, and
dosing regimens often need alteration in patients receiving CRRT. Doses required to generate
predictable serum concentrations can be calculated from known patient parameters such as
replacement fluid and dialysate flow rate, sieving coefficients, and desired serum
concentrations. However, pharmacokinetic studies must be performed in CRRT patients to
generate drug removal constants or sieving coefficients. Of note, the clearance of drugs by
conventional hemodialysis cannot be used to extrapolate clearances with CRRT secondary to
differences in ultrafiltration rates and dialysis membranes. The investigators propose an
open label study to obtain peramivir pharmacokinetics in patients undergoing CRRT.
continuous renal replacement therapy CRRT - either Continuous veno-venous hemofiltration
(CVVH) +/- dialysis (CVVHD). CRRT is commonly utilized in the hospital setting for patients
with acute kidney injury for metabolic correction, slow continuous fluid removal, and to
maintain hemodynamic stability. CRRT commonly alters drug disposition and clearance, and
dosing regimens often need alteration in patients receiving CRRT. Doses required to generate
predictable serum concentrations can be calculated from known patient parameters such as
replacement fluid and dialysate flow rate, sieving coefficients, and desired serum
concentrations. However, pharmacokinetic studies must be performed in CRRT patients to
generate drug removal constants or sieving coefficients. Of note, the clearance of drugs by
conventional hemodialysis cannot be used to extrapolate clearances with CRRT secondary to
differences in ultrafiltration rates and dialysis membranes. The investigators propose an
open label study to obtain peramivir pharmacokinetics in patients undergoing CRRT.
This study has been closed. No patients were enrolled as the peramivir EUA was rescinded.
Inclusion Criteria
- Patient is hospitalized and undergoing continuous renal replacement therapy (CRRT) as
a result of the clinical management of the patient (i.e. CRRT is not initiated for the
purpose of this study).
- Patient is receiving peramivir for a positive rapid antigen test for influenza or on
the basis of clinical suspicion with a high local epidemiological prevalence of H1N1
disease.
- Patient has a CRRT blood flow rate greater than or equal to 100 mL/min with an
ultrafiltrate +/- dialysis flow rate greater than or equal to 3000mL/hr,
- The patient is anticipated to require CRRT and peramivir treatment for a full 24 hours
(i.e. life expectancy is not less than 24 hours).
Exclusion Criteria
- The patient has received greater than 5 doses of peramivir.
- The subject has a pre-existing illness that, in the opinion of the investigator, would
place the subject at an unreasonably increased risk through participation in this
study.
- The patient is receiving CRRT utilizing a pre-membrane dilution method.
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