Critical IllnessNCT02242006
Antimicrobial Pharmacokinetics in Critically Ill Adults During Sustained Low Efficiency Dialysis (SLED)
An observational study of Critical Illness and Kidney Injury, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Kidney Injury, Pharmacokinetics
- What is being tested?
- serial serum sampling for quantification of drug concentration
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: critically ill adults admitted to an ICU
Who may be able to join
- 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.
Who cannot join
- 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 βHCG 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Critical Illness, Kidney Injury, Pharmacokinetics
- Being tested
- serial serum sampling for quantification of drug concentration
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serial serum sampling for quantification of drug concentrationOther
| Study group | Role | What they receive |
|---|---|---|
| piperacillin/tazobactam | Serial serum sampling of patients receiving piperacillin/tazobactam and SLED simultaneously Receives: Other: serial serum sampling for quantification of drug concentration | |
| meropenem | Serial serum sampling of patients receiving meropenem and SLED simultaneously Receives: Other: serial serum sampling for quantification of drug concentration | |
| vancomycin | Serial serum sampling of patients receiving vancomycin and SLED simultaneously Receives: Other: serial serum sampling for quantification of drug concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
drug clearance
Serial serum samples will be obtained after drug administration and during SLED to determine drug clearance during SLED.
Measured: 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.
Measured: During the first run of SLED after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242006
- Sponsor's protocol ID
- 20140429
- Status last verified
- Sep 2014
- First submitted
- 9 Sep 2014
- Last updated
- 29 Apr 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Pharmacokinetics in Critically Ill Adults During Sustained Low Efficiency Dialysis (SLED)
- ClinicalTrials.gov ID
- NCT02242006
- Acronym / sponsor ID
- 20140429
- Conditions
- Critical Illness, Kidney Injury, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| piperacillin/tazobactam | – | Other: serial serum sampling for quantification of drug concentrationSerial serum sampling of patients receiving piperacillin/tazobactam and SLED simultaneously |
| meropenem | – | Other: serial serum sampling for quantification of drug concentrationSerial serum sampling of patients receiving meropenem and SLED simultaneously |
| vancomycin | – | Other: serial serum sampling for quantification of drug concentrationSerial serum sampling of patients receiving vancomycin and SLED simultaneously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill adults admitted to an ICU
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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 βHCG 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serial serum sampling for quantification of drug concentration | Other | meropenem, piperacillin/tazobactam, vancomycin |
Primary outcome
drug clearance
Time frame: During the first run of SLED after study inclusion
Serial serum samples will be obtained after drug administration and during SLED to determine drug clearance during SLED.
volume of distribution
Time frame: During the first run of SLED after study inclusion
Serial serum samples will be obtained after drug administration and during SLED to determine drug volume of distribition during SLED.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Kidney Injury, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
drug clearance (time frame: During the first run of SLED after study inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.