Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients

Phase 4

Withdrawn

• Conditions: Renal Failure
• Interventions: Other: pharmacokinetic monitoring

• Registration Number: NCT01507532
• Lead Sponsor: Midwestern University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-11
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-17
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ceftazidime	pharmacokinetic monitoring	pharmacokinetic monitoring

Primary Outcome Measures

Name	Time	Method
Determine clearance of ceftazidime in hemodialysis	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).

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States