Sampling antibiotics in renal replacement therapy
Research type
Research Study
Full title
SaMpling Antibiotics in Renal Replacement Therapy (SMARRT) - Multi-national prospective pharmacokinetic study
IRAS ID
132444
Contact name
Marlies Ostermann
Contact email
Research summary
There is evidence that some patients in the Intensive Care Unit (ICU) who have a serious infection and acute kidney injury (AKI) receiving renal replacement therapy (RRT), have inadequate antibiotic levels in their blood. Guidelines for effective dosing of antibiotics whilst on RRT are not easily available because the practice of RRT is very variable and different patients may need different types of RRT, resulting in significant variations in antibiotic levels in the blood.
SMARRT is an observational international prospective pharmacokinetic study which aims to enrol 450 critically ill patients who are on RRT and are prescribed Vancomycin, Piperacillin-Tazobactam and/or Meropenem for an infection. The main aim is to develop optimised antibiotic dosing guidelines for ICU patients with life-threatening infections that take into account patient characteristics and the type of RRT they are prescribed. This will be achieved through completion of the following:
1. Collection of blood and urine samples for antibiotic levels.
2. Detailed description of the demographic, clinical, RRT and plasma antibiotic concentration-time data.
3. Robust pharmacokinetic and statistical analysis of the data collected to develop an enhanced preliminary prediction algorithm for antibiotic dosing.
Blood sampling will occur during study days 1-2 and then a second time during a dosing interval between days 3-6. Effluent and urine collection samples will also be collected on these 2 study days. Data on residual renal function, filter age, filter settings and demographic data will be recorded. Patients will be followed up 28 days after enrolment into the study to evaluate 28-day mortality.
The primary endpoints are pharmacokinetic parameters in various forms of RRT. The secondary endpoint is 28 day mortality.
Samples for drug analysis will be shipped to The University of Queensland, Australia for processing and laboratory analysis. An aliquot of the samples will be stored locally for future analysis of inflammatory markers.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
13/LO/1598
Date of REC Opinion
6 Jan 2014
REC opinion
Further Information Favourable Opinion