NCT00877370

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 28, 2012

Completed
Last Updated

September 28, 2012

Status Verified

August 1, 2012

Enrollment Period

2.1 years

First QC Date

April 3, 2009

Results QC Date

August 29, 2012

Last Update Submit

August 29, 2012

Conditions

Acute Kidney Failure

Keywords

ertapenemcontinuous hemodialysispharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Ertapenem Transmembrane Clearance by Continuous Hemodialysis.

    24 hours after receiving first 1 gram dose

Study Arms (1)

ertapenem

EXPERIMENTAL

subjects will receive ertapenem while receiving CVVHD

Drug: ertapenem

Interventions

ertapenemDRUG

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.

Also known as: Invanz
ertapenem

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized in ICU
  • Receiving Continuous hemodialysis
  • Prescribed ertapenem
  • Informed consent granted

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan University Hospital

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Eyler RF, Vilay AM, Nader AM, Heung M, Pleva M, Sowinski KM, DePestel DD, Sorgel F, Kinzig M, Mueller BA. Pharmacokinetics of ertapenem in critically ill patients receiving continuous venovenous hemodialysis or hemodiafiltration. Antimicrob Agents Chemother. 2014;58(3):1320-6. doi: 10.1128/AAC.02090-12. Epub 2013 Dec 9.

    PMID: 24323468DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Bruce A. Mueller
Organization
University of Michigan
muellerb@umich.edu
(734) 615-4578

Study Officials

  • Bruce A Mueller, Pharm.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pharmacy

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 7, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

September 28, 2012

Results First Posted

September 28, 2012

Record last verified: 2012-08

Locations

US(1)