Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients

Midwestern University

Status and phase: Withdrawn; Phase 4

Conditions: Renal Failure

Treatments: Other: pharmacokinetic monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01507532

STU00056702

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Ceftazidime

Other group

Description:

pharmacokinetic monitoring

Treatment:

Other: pharmacokinetic monitoring