Pharmacokinetics of Vancomycin in the ICU in Renal Replacement Therapy

• ClinicalTrials.gov Identifier: NCT00848809
• Recruitment Status: Withdrawn
• First Posted: February 20, 2009
• Last Update Posted: April 22, 2015
• Sponsor: Avera McKennan Hospital & University Health Center
• Information provided by: Avera McKennan Hospital & University Health Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Acute Kidney Injury	Procedure: Blood sample

Detailed 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

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Pharmacokinetics of Vancomycin in Various Modalities of Renal Replacement Therapy in the Intensive Care Unit
• Study Start Date: December 2008
• Actual Primary Completion Date: April 2009
• Actual Study Completion Date: April 2009

Groups and Cohorts

Group/Cohort	Intervention/treatment
1; Slow-low efficiency daily dialysis group	Procedure: Blood sample; 9 blood samples will be sent to the laboratory for the subjects in the SLED cohort; Other Name: Vancomycin level
2; Intermittent Hemodialysis group	Procedure: Blood sample; 10 blood samples will be collected and sent to the laboratory for the subjects in the intermittent hemodialysis cohort.; Other Name: Vancomycin level

Outcome Measures

Primary Outcome Measures :

1. To determine the effect of different types of renal replacement therapies on the elimination and volume of distribution of vancomycin. [ Time Frame: 4 months ]

Biospecimen Retention:   None Retained

Whole blood

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients must be admitted to the intensive care unit at Avera McKennan Hospital in Sioux Falls, SD.

Criteria

Inclusion Criteria:

• > 18 years of age
• One of the following types of dialysis modalities implemented:

Slow-low efficiency daily dialysis Intermittent hemodialysis

• Use of study medication (vancomycin)

Exclusion Criteria:

• Inability to give informed consent

Contacts and Locations

Locations

United States, South Dakota

Avera McKennan Hospital and University Health Center

Sioux Falls, South Dakota, United States, 57117

Sponsors and Collaborators

Avera McKennan Hospital & University Health Center

Investigators

• Principal Investigator: Bradley Beck, Pharm.D.; Avera McKennan Hospital and University Health Center

More Information

Publications:

Kielstein JT, Czock D, Schöpke T, Hafer C, Bode-Böger SM, Kuse E, Keller F, Fliser D. Pharmacokinetics and total elimination of meropenem and vancomycin in intensive care unit patients undergoing extended daily dialysis. Crit Care Med. 2006 Jan;34(1):51-6.

Trotman RL, Williamson JC, Shoemaker DM, Salzer WL. Antibiotic dosing in critically ill adult patients receiving continuous renal replacement therapy. Clin Infect Dis. 2005 Oct 15;41(8):1159-66. Epub 2005 Sep 12. Review.

Pai AB, Pai MP. Vancomycin dosing in high flux hemodialysis: a limited-sampling algorithm. Am J Health Syst Pharm. 2004 Sep 1;61(17):1812-6.

• Responsible Party: Bradley Beck, Pharm.D., Avera McKennan Hospital and University Health Center
• ClinicalTrials.gov Identifier: NCT00848809 History of Changes
• Other Study ID Numbers: 2008.073
• First Posted: February 20, 2009
• Last Update Posted: April 22, 2015
• Last Verified: April 2015

Keywords provided by Avera McKennan Hospital & University Health Center:

Acute kidney injury; Vancomycin therapy; Slow-low efficiency daily dialysis; Intermittent Hemodialysis; Kidney; Vancomycin; Hemofiltration

Additional relevant MeSH terms:

Acute Kidney Injury; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Vancomycin; Anti-Bacterial Agents; Anti-Infective Agents