Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
10 May 2021 |
Main ID: |
NCT02242006 |
Date of registration:
|
09/09/2014 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Antimicrobial Pharmacokinetics in Critically Ill Adults During Sustained Low Efficiency Dialysis (SLED)
|
Scientific title:
|
Antimicrobial Pharmacokinetics in Critically Ill Adults During Sustained Low Efficiency Dialysis (SLED) |
Date of first enrolment:
|
October 2014 |
Target sample size:
|
90 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02242006 |
Study type:
|
Observational |
Study design:
|
|
Phase:
|
|
|
Countries of recruitment
|
Canada
| | | | | | | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Critically ill adults [age = 18] admitted to one of two of the medical/surgical
intensive care units (ICUs) of The Ottawa Hospital, who require SLED and are or will
receive meropenem, piperacillin-tazobactam or vancomycin therapy at any dose.
Exclusion Criteria:
- Patients for whom participation via the informed consent process is denied.
- Critically ill patients with a hypermetabolic state due to >25% coverage of body
surface area burn, cystic fibrosis, spinal cord injury, bariatric patients (defined as
>150kg total body weight)
- Patient is pregnant as per a positive serum or urine ßHCG qualitative assay
- Patient does not have a closed-system arterial or central venous catheter (to minimize
blood wastage)
- Patients receiving concomitant drugs known to interact with the metabolism or
clearance of the antimicrobial of interest according to Micromedex 2.0 (Truven Health
Analytics Inc 2013)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Pharmacokinetics
|
Critical Illness
|
Kidney Injury
|
Intervention(s)
|
Other: serial serum sampling for quantification of drug concentration
|
Primary Outcome(s)
|
drug clearance
[Time Frame: During the first run of SLED after study inclusion]
|
volume of distribution
[Time Frame: During the first run of SLED after study inclusion]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|