Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients

Renal Failure Clinical Trial

Official title:

Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01507532
• Other study ID #: STU00056702
• Status: Withdrawn
• Phase: Phase 4
• First received: January 3, 2012
• Last updated: March 17, 2018
• Start date: January 2012
• Est. completion date: January 2016

Study information

• Verified date: March 2018
• Source: Midwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Other:
• pharmacokinetic monitoring
pharmacokinetic monitoring

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Midwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	time 0 = end of infusion) up to 72 hours