Back to resultsPharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients
Primary Purpose
Renal Failure
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
pharmacokinetic monitoring
Sponsored by
About this trial
This is an interventional other trial for Renal Failure
Eligibility 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
Sites / Locations
- Northwestern Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ceftazidime
Arm Description
pharmacokinetic monitoring
Outcomes
Primary Outcome Measures
Determine clearance of ceftazidime in hemodialysis
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01507532
Brief Title
Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients
Official Title
Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
did not enroll a patient
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Midwestern University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ceftazidime
Arm Type
Other
Arm Description
pharmacokinetic monitoring
Intervention Type
Other
Intervention Name(s)
pharmacokinetic monitoring
Other Intervention Name(s)
Fortaz
Intervention Description
pharmacokinetic monitoring
Primary Outcome Measure Information:
Title
Determine clearance of ceftazidime in hemodialysis
Description
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).
Time Frame
time 0 = end of infusion) up to 72 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc H Scheetz, PharmD
Organizational Affiliation
Midwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients
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