- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02242006
Antimicrobial Pharmacokinetics in Critically Ill Adults During Sustained Low Efficiency Dialysis (SLED)
April 27, 2021 updated by: Ottawa Hospital Research Institute
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
critically ill adults admitted to an ICU
Description
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 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
piperacillin/tazobactam
Serial serum sampling of patients receiving piperacillin/tazobactam and SLED simultaneously
|
|
meropenem
Serial serum sampling of patients receiving meropenem and SLED simultaneously
|
|
vancomycin
Serial serum sampling of patients receiving vancomycin and SLED simultaneously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
During the first run of SLED after study inclusion
|
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.
|
During the first run of SLED after study inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
September 9, 2014
First Submitted That Met QC Criteria
September 15, 2014
First Posted (Estimate)
September 16, 2014
Study Record Updates
Last Update Posted (Actual)
April 29, 2021
Last Update Submitted That Met QC Criteria
April 27, 2021
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20140429
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Critical Illness
-
Duke UniversityNational Institute of Neurological Disorders and Stroke (NINDS); National Institutes...CompletedNeonatal Critical Illness | Pediatric Critical IllnessUnited States
-
Yale UniversityNational Institute on Aging (NIA)RecruitingCritical Illness | Illness, CriticalUnited States
-
McMaster UniversityLondon Health Sciences Centre; McMaster Children's Hospital; Canadian Critical...CompletedPediatric Critical IllnessCanada
-
Boston Children's HospitalCompleted
-
St Helens & Knowsley Teaching Hospitals NHS TrustManchester University NHS Foundation TrustCompleted
-
Sándor BeniczkyUniversity of Aarhus; Danish Council for Independent Research; Søster og Verner...CompletedCritical Illness Myopathy | Myopathy Critical IllnessDenmark
-
University Hospital Birmingham NHS Foundation TrustCompletedRehabilitation After Critical Illness
-
Hospital de Clinicas de Porto AlegreUnknownCritical Illness PolyneuropathiesBrazil
-
Peking Union Medical College HospitalBaxter Healthcare CorporationUnknownNutrition Therapy for Critical Illness
-
Assistance Publique - Hôpitaux de ParisRecruitingCritical Illness Related Corticosteroids InsufficiencyFrance
Clinical Trials on serial serum sampling for quantification of drug concentration
-
University Hospital, GhentScientific research fund BrugesCompleted
-
Azienda Ospedaliera Universitaria Integrata VeronaSocieta Italiana dell'Ipertensione ArteriosaNot yet recruitingDyslipidemias | Treatment Adherence | Arterial Hypertension | Antihypertensive Drugs | StatinsItaly
-
University of LatviaUppsala University; Pontificia Universidad Catolica de Chile; Technion, Israel... and other collaboratorsRecruitingScreening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach (VOGAS)Gastric Cancer | Gastric Dysplasia | Atrophic Gastritis | H.Pylori InfectionBrazil, Chile, Colombia, Latvia, Ukraine
-
PfizerCompleted
-
University of LatviaKarolinska Institutet; Lithuanian University of Health Sciences; Technion, Israel... and other collaboratorsCompletedGastric Cancer | Colorectal Cancer | Colorectal Adenoma | Intestinal Metaplasia | Atrophic Gastritis | H.Pylori Infection | Peptic Ulcer Disease | Normal Control | Average-risk General PopulationLatvia, Lithuania
-
The University of Hong KongSuspendedPulmonary Hypertension | Methamphetamine AbuseHong Kong
-
University of LatviaTechnion, Israel Institute of Technology; Riga East University Hospital; JLM...Enrolling by invitationLiver Cirrhosis | Inflammatory Bowel Diseases | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Peptic Ulcer | Tuberculosis | Pancreatitis, Chronic | Liver Cancer | Colorectal Adenoma | Intestinal Metaplasia | Colorectal Polyp | Gastric Dysplasia | Atrophic Gastritis | Other Infectious Diseases | Flu, HumanLatvia
-
Beni-Suef UniversityCairo UniversityUnknown
-
Gilead SciencesCompleted
-
Gilead SciencesCompletedHIV Infections | HIVUnited States, Puerto Rico