Clinical Trials Logo
  1. Home
  2. Hemodialysis Complication
  3. NCT04319328

Is Cefazolin, Ceftazidime and Ciprofloxacin Dosing Optimal in Hemodialysis Patients?

End Stage Renal Disease Clinical Trial

Official title:
Pharmacokinetic Evaluation of Cefazolin, Ceftazidime, and Ciprofloxacin in Chronic Hemodialysis Patients

Clinical Trial Summary

This study aims to optimize the dosing of cefazolin, ceftazidime, and ciprofloxacin for patients on high-flux hemodialysis. For each antibiotic 20 participants will be enrolled and three blood samples will be collected from each participant. Antibiotic levels will be measured in each blood sample. This data will be used to develop population-pharmacokinetic models for each antibiotic. Finally, Monte Carlo simulations will be used to develop evidence-based dosing recommendations.

Clinical Trial Description

The goal of this study is to optimize the dosing of three commonly used antibiotics, thereby improving the treatment of serious, often life-threatening infections in patients on intermittent high-flux hemodialysis (iHFHD). The hypothesis is that current antibiotic dosing is suboptimal, thereby increasing the risk of poor outcomes including treatment failure, adverse drug reactions and antibiotic resistance. A prospective, non-interventional pharmacokinetic (PK) study of cefazolin, ceftazidime, and ciprofloxacin will be conducted in the St. Boniface Hospital outpatient hemodialysis unit. The 1st objective of this study is to measure the free and total plasma concentrations of cefazolin, ceftazidime, and ciprofloxacin in adult patients on iHFHD and receiving antibiotic therapy for suspected or proven infection. For each antibiotic 20 participants will be enrolled and three blood samples will be collected from each participant. Antibiotic concentrations will be measured using an ultra high performance liquid chromatograph mass spectrometer. Total antibiotic concentrations in plasma will be measured in all patient samples. To describe protein binding, free levels will also be measured in the first two samples collected from the first 10 patients for each antibiotic. The 2nd objective of this study is to characterize the PK of cefazolin, ceftazidime, and ciprofloxacin in patients on iHFHD using population-PK modelling. Covariates with potential influence on PK such as gender, age, body weight, dialyzer type, blood and dialysate flow rates, duration of dialysis and Kt/Vurea will be investigated, and incorporated as appropriate. For each antibiotic, the best PK model will be selected using established goodness-of-fit tests, and then independently validated. The 3rd objective of this study is to translate findings to patient care using Monte Carlo simulations to evaluate conventional antibiotic dosing and develop optimized evidence-based dosing recommendations for cefazolin, ceftazidime, and ciprofloxacin in patients on iHFHD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04319328
Study type Observational
Source University of Manitoba
Contact
Status Completed
Phase
Start date October 18, 2019
Completion date April 30, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT04076488 - Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases N/A
Completed NCT03289650 - Extended Release Tacrolimus vs. Twice-Daily Tacrolimus Phase 3
Completed NCT04042324 - A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients Phase 1/Phase 2
Completed NCT01242904 - Use of a Bimodal Solution for Peritoneal Dialysis Phase 2
Active, not recruiting NCT03183245 - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis Phase 3
Completed NCT03257410 - Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients N/A
Completed NCT03627299 - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors Phase 4
Recruiting NCT05917795 - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates N/A
Terminated NCT03539861 - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients N/A
Withdrawn NCT02130817 - Belatacept in Kidney Transplantation of Moderately Sensitized Patients Phase 4
Completed NCT05540457 - Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis) N/A
Not yet recruiting NCT04900610 - The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis N/A
Recruiting NCT02176434 - Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease N/A
Active, not recruiting NCT02581449 - Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis Phase 2
Completed NCT02832466 - Quantifying the Deterioration of Physical Function in Renal Patients N/A
Completed NCT02134314 - C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI Phase 1/Phase 2
Completed NCT02215655 - Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence N/A
Completed NCT02830490 - Reliability of Functional Measures in Hemodialysis Patient. N/A
Completed NCT02832440 - Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis N/A
Recruiting NCT01912001 - Virtual Ward for Home Dialysis N/A