Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis

Acute Kidney Failure Clinical Trial

Official title:

Pharmacokinetics of Invanz® (Ertapenem) in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877370
• Other study ID #: HUM00022460
• Status: Completed
• Phase: Phase 4
• First received: April 3, 2009
• Last updated: August 29, 2012
• Start date: February 2009
• Est. completion date: March 2011

Study information

• Verified date: August 2012
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Critically ill patients in the intensive care unit often receive continuous hemodialysis to treat their kidney failure. Ertapenem is an antibiotic often used in these patients. Continuous dialysis may remove ertapenem, putting patients at risk for inappropriate treatment of their infection. This study will determine how much ertapenem is removed by continuous hemodialysis.

Description:

Subjects receiving CVVHD will receive a one gram dose of ertapenem. Serial blood samples over 24 hours will be taken to assess the ertapenem blood concentrations over time. Spent dialysate and urine samples (if any) will also be measured for ertapenem content to determine how much drug is removed by CVVHD and kidneys. A pharmacokinetic evaluation will be made to determine what is the most appropriate dose for this drug in patients receiving CVVHD to achieve pharmacokinetic and pharmacodynamic goals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospitalized in ICU

• Receiving Continuous hemodialysis

• Prescribed ertapenem

• Informed consent granted

Exclusion Criteria:

• < 18 years of age

• Allergy to ertapenem or other carbapenem antibiotic

• Severe, life-threatening reaction to penicillin or cephalosporins

• Patients experiencing or with history of CNS disorders (eg: seizure, stroke)

• Patients experiencing CNS infection

• Inability to complete 24 hours of CVVHD

• Concurrent use of other extracorporeal therapies such as extracorporeal membrane oxygenation, plasmapheresis or intermittent hemodialysis

• Inability to obtain informed consent

• Pregnant and/or breastfeeding women

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Kidney Failure
• Acute Kidney Injury
• Renal Insufficiency

Intervention

Drug:
• ertapenem
One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained.

Locations

Country	Name	City	State
United States	University of Michigan University Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ertapenem Transmembrane Clearance by Continuous Hemodialysis.		24 hours after receiving first 1 gram dose	No