Pharmacokinetics of Vancomycin in the ICU in Renal Replacement Therapy

Acute Kidney Injury Clinical Trial

Official title:

Pharmacokinetics of Vancomycin in Various Modalities of Renal Replacement Therapy in the Intensive Care Unit

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00848809
• Other study ID #: 2008.073
• Status: Withdrawn
• Phase: N/A
• First received: February 19, 2009
• Last updated: April 21, 2015
• Start date: December 2008
• Est. completion date: April 2009

Study information

• Verified date: April 2015
• Source: Avera McKennan Hospital & University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Procedure:
• Blood sample
9 blood samples will be sent to the laboratory for the subjects in the SLED cohort
• Blood sample
10 blood samples will be collected and sent to the laboratory for the subjects in the intermittent hemodialysis cohort.

Locations

Country	Name	City	State
United States	Avera McKennan Hospital and University Health Center	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Avera McKennan Hospital & University Health Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effect of different types of renal replacement therapies on the elimination and volume of distribution of vancomycin.		4 months	No