Pharmacokinetics of Vancomycin in the ICU in Renal Replacement Therapy

Status Withdrawn

Clinical Trial Summary

This study is an observational analysis that monitors the effect of different dialysis methods on vancomycin levels when patients are critically ill. No changes are made to therapy based on levels, but levels are checked more frequently than normal. The primary dialysis methods being studied are SLED (slow-low efficiency daily) dialysis and intermittent hemodialysis. Vancomycin is the only medication being evaluated in this study. This study will provide detailed information on how to dose vancomycin in patients that are on dialysis in the intensive care unit.

Clinical Trial Description

The proposed study will evaluate the pharmacokinetics of vancomycin in patients that are on being treated with various types of renal replacement therapy. The renal replacement therapies studied in this trial will be slow-low efficiency daily (SLED) dialysis and intermittent hemodialysis. This data will be collected and plotted for vancomycin for each dialysis mechanism utilized and plotted on drug concentration versus time graphs to determine drug clearance in each type of renal replacement therapy. Subjects will have blood samples drawn and sent to the laboratory according to the dialysis method studied (9 for SLED dialysis and 10 samples for intermittent hemodialysis). Serial levels will be drawn prior to the drug being administered and after the drug is infused to assess the clearance and distribution of vancomycin. Study drug levels will be drawn from blood that is already available in the laboratory when timing of such samples is appropriate, in order to limit the amount of blood that is drawn from each study subject. A total of 30 milliliters of blood will be collected from each subject for any one study arm they fit into. Blood will be collected no more than two times per week and only more than once in a particular patient if their dialysis regimen changes. A single particular subject will only be able to supply blood samples once for each dialysis regimen being studied. This study would allow for the data collection of vancomycin levels at several time points during renal replacement therapy to assess the pharmacokinetic parameters associated with vancomycin dosing in each specialized patient-dialysis combination. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Acute Kidney Injury

Clinical Trial Details

NCT number	NCT00848809
Study type	Observational
Source	Avera McKennan Hospital & University Health Center
Contact
Status	Withdrawn
Phase	N/A
Start date	December 2008
Completion date	April 2009

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05538351` - A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
Recruiting	`NCT06027788` - CTSN Embolic Protection Trial	N/A
Completed	`NCT03938038` - Guidance of Ultrasound in Intensive Care to Direct Euvolemia	N/A
Recruiting	`NCT05805709` - A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial	N/A
Recruiting	`NCT05318196` - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Recruiting	`NCT05897840` - Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients	N/A
Recruiting	`NCT04986137` - Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Cirrhosis
Terminated	`NCT04293744` - Acute Kidney Injury After Cardiac Surgery	N/A
Completed	`NCT04095143` - Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
Not yet recruiting	`NCT06026592` - Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
Not yet recruiting	`NCT06064305` - Transcriptional and Proteomic Analysis of Acute Kidney Injury
Terminated	`NCT03438877` - Intensive Versus Regular Dosage For PD In AKI.	N/A
Terminated	`NCT03305549` - Recovery After Dialysis-Requiring Acute Kidney Injury	N/A
Completed	`NCT05990660` - Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery	N/A
Completed	`NCT04062994` - A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
Terminated	`NCT02860130` - Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)	Phase 3
Completed	`NCT06000098` - Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy
Not yet recruiting	`NCT05548725` - Relation Between Acute Kidney Injury and Mineral Bone Disease
Completed	`NCT02665377` - Prevention of Akute Kidney Injury, Hearttransplant, ANP	Phase 3
Terminated	`NCT03539861` - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.