An observational study in Critical Illness, Kidney Injury and Pharmacokinetics, sponsored by Ottawa Hospital Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-29.
Sponsored by Ottawa Hospital Research Institute · Observational
Severe acute kidney injury (AKI) is a common complication of critical illness affecting almost half of all patients with septic shock. Extracorporeal renal replacement therapy is a cornerstone in the management of AKI in these patients. Options for renal replacement therapy include continuous renal replacement (CRRT) therapy, intermittent dialysis (IHD) or a hybrid form of the two called sustained low efficiency dialysis (SLED). Globally there is a push to switch from traditional CRRT to SLED. Although there are resource and financial comparative benefits to SLED there is almost no literature describing how to dose antimicrobials (or other drugs for that matter). It appears that drug clearance on SLED may be more efficient than CRRT but not as efficient as IHD making extrapolation from these bodies of literature inappropriate for SLED. The investigators are proposing to conduct the population pharmacokinetic studies for the three most commonly used antimicrobials in critically ill patients receiving SLED therapy (piperacillin-tazobactam, meropenem and vancomycin). Population pharmacokinetic modeling of these drugs will provide estimates and sources of variability around pharmacokinetic parameters that will subsequently be used for Monte Carlo simulation to determine the most appropriate dosing regimens to achieve therapeutic targets while minimizing the risk of toxicity.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 90 is below the median of 130 across 867 observational studies indexed under Critical Illness.
Browse Critical Illness studies →Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
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critically ill adults admitted to an ICU
Exclusion Criteria:
Serial serum sampling of patients receiving piperacillin/tazobactam and SLED simultaneously
Other: serial serum sampling for quantification of drug concentration
Serial serum sampling of patients receiving meropenem and SLED simultaneously
Other: serial serum sampling for quantification of drug concentration
Serial serum sampling of patients receiving vancomycin and SLED simultaneously
Other: serial serum sampling for quantification of drug concentration
drug clearance
Serial serum samples will be obtained after drug administration and during SLED to determine drug clearance during SLED.
Time frame: During the first run of SLED after study inclusion
volume of distribution
Serial serum samples will be obtained after drug administration and during SLED to determine drug volume of distribition during SLED.
Time frame: During the first run of SLED after study inclusion
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Ottawa Hospital Research Institute