Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Midwestern University
Sponsor:
Information provided by (Responsible Party):
Marc Scheetz, Midwestern University
ClinicalTrials.gov Identifier:
NCT01507532
First received: January 3, 2012
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

Ceftazidime is a broad spectrum cephalosporin with high activity against a variety of Gram-negative pathogens, including Pseudomonas aeruginosa. An open-label study of intravenous ceftazidime pharmacokinetics will be performed in patients undergoing intermittent hemodialysis at Northwestern Memorial Hospital to determine the clearance of ceftazidime in high flux hemodialysis.


Condition Intervention Phase
Renal Failure
Other: pharmacokinetic monitoring
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Midwestern University:

Primary Outcome Measures:
  • Determine clearance of ceftazidime in hemodialysis [ Time Frame: time 0 = end of infusion) up to 72 hours ] [ Designated as safety issue: No ]
    Serial blood draws will be performed at the following times in hours (time 0 = end of infusion): the time immediately before hemodialysis, 0.5, 4, and immediately before the next dose of ceftazidime. Any extra blood from samples drawn by the primary provider per routine care during the study period will also be considered for capture if it would routinely be discarded. The blood draws for this study will occur over a period of 72 hours (i.e. until the day of the following hemodialysis session).


Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ceftazidime
pharmacokinetic monitoring
Other: pharmacokinetic monitoring
pharmacokinetic monitoring
Other Name: Fortaz

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible patients are male or female adults ≥18 years of age with an expected hospital stay of at least 48 hours, who have end-stage renal disease and been receiving intermittent hemodialysis for at least 90 days.
  • Eligible patients will additionally have either central or peripheral intravenous access, and will already be prescribed ceftazidime per their primary providers.
  • Written informed consent in a form approved by Northwestern Memorial Hospital, Northwestern University Institutional Review Board, and Midwestern University Institutional Review Board will be completed by the patient prior to enrollment.

Exclusion Criteria:

  • Patients that only receive one dose of ceftazidime in total
  • Patients with potentially altered pharmacokinetic parameters (pregnant patients, burn patients, and those that are morbidly obese (BMI ≥ 40 kg/m2).
  • Not meeting inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507532

Contacts
Contact: Marc H Scheetz, PharmD, MSc 312.926.2546 mscheetz@nmh.org
Contact: Angela Loo, PharmD 312.695.5955 ALOO@nmh.org

Locations
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Scheetz       mscheetz@nmh.org   
Sub-Investigator: Angela Loo, PharmD         
Sub-Investigator: Evan Anderson, MD         
Sub-Investigator: Cybele Ghossein, MD         
Principal Investigator: Marc H Scheetz, PharmD, MSc         
Sponsors and Collaborators
Midwestern University
Investigators
Principal Investigator: Marc H Scheetz, PharmD Midwestern University
  More Information

No publications provided

Responsible Party: Marc Scheetz, Assistant Professor, Midwestern University
ClinicalTrials.gov Identifier: NCT01507532     History of Changes
Other Study ID Numbers: STU00056702
Study First Received: January 3, 2012
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Ceftazidime
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014