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Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients

This study has been withdrawn prior to enrollment.
(did not enroll a patient)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01507532
First Posted: January 11, 2012
Last Update Posted: August 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marc Scheetz, Midwestern University
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Marc Scheetz, Midwestern University:

Primary Outcome Measures:
  • Determine clearance of ceftazidime in hemodialysis [ Time Frame: time 0 = end of infusion) up to 72 hours ]
    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).


Enrollment: 0
Study Start Date: January 2012
Study Completion Date: January 2016
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507532


Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Midwestern University
Investigators
Principal Investigator: Marc H Scheetz, PharmD Midwestern University
  More Information

Responsible Party: Marc Scheetz, Associate Professor, Midwestern University
ClinicalTrials.gov Identifier: NCT01507532     History of Changes
Other Study ID Numbers: STU00056702
First Submitted: January 3, 2012
First Posted: January 11, 2012
Last Update Posted: August 29, 2017
Last Verified: August 2017

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