The study population concerns patients in participating Intensive care unit simultaneously requiring Renal Replacement Therapy and intravenous antibiotic therapy (Piperacillin-Tazobactam, Meropenem or Vancomycin).
Conditions
Interventions
Trade Name: PIPERACILLIN/TAZOBACTAM
Product Name: PIPERACILLIN/TAZOBACTAM
Pharmaceutical Form: Powder and solution for solution for injection
Trade Name: MEROPENEM
Product Name: MEROPENEM
Pharmaceuti
Sponsors
CHU de NIMES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The patient (or his/her authorized representative) has been correctly informed • The patient (or his/her authorized representative) must have given his/her informed and signed consent. • The patient must be insured or beneficiary of a health insurance plan. • The patient is at least 18 years old. • AKI requiring RRT (defined according to RIFLE, AKIN or KDIGO criteria41) • Clinical indication for IV Piperacillin – Tazobactam, Meropenem or Vancomycin • Expected do be on filter for at least 4 days • Presence of intra-arterial line for blood sampling if RRT filter port sampling not possible Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • The patient is participating in another study that my interfere with the results or conclusions of this study • Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study • The patient is in an exclusion period determined by a previous study • The patient is under judicial protection • The patient is an adult under guardianship • The patient (or his/her authorized representative) refuses to sign the consent • It is impossible to correctly inform the patient (or his/her authorized representative) • The patient is pregnant, parturient or breastfeeding • Imminent death / not expected to survive, etc. • Major bleeding or Hb< 70 g/L or platelets < 20.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Aim 1. Describe detailed demographic, clinical, RRT and plasma antibiotic concentration-time data in a large ICU patient cohort. Aim 2. Evaluate the statistical distributions of PK parameters and determine the optimum antibiotic dosing limits during different RRTs. This analysis will explore appropriate models to determine the confidence boundaries of PK parameters, clearance and Vd for each antibiotic during the different RRT modes and settings and will then use a simulation approach using these basic models to define the range of appropriate doses for the antibiotics. Aim 3. Determine the effect of various patient and RRT factors on PK parameters. This analysis will provide the effect size and significance of various patient and RRT factors on the confidence boundaries of individual PK parameters obtained from basic models (Aim 2). Aim 4. Develop an enhanced preliminary prediction algorithm for antibiotic dosing. ;Primary end point(s): • Description of pharmacokinetic parameters in various forms of RRT;Timepoint(s) of evaluation of this end point: 6 days;Main Objective: The aim of the SMARRT Study is to develop optimised antibiotic dosing guidelines for ICU patients with life-threatening infections that account for patient characteristics and the type of RRT they are prescribed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 28 day mortality ;Timepoint(s) of evaluation of this end point: 28 days | — |
Countries
France
Contacts
Public ContactDirection de la recherche
CHU de NIMES
Outcome results
None listed