An observational study in Critical Illness, Infectious Disease and Children, sponsored by Radboud University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2020-03-13.
Sponsored by Radboud University Medical Center · Observational
Infections are common on the Intensive Care for both adult and pediatric patients. Adequately dosing antibiotic treatment is of vital importance but both under- and overdosing is frequent due to pathophysiological changes during critical illness. Moreover, the interplay of age and critical illness is even more understudied.
To optimize antibiotic dosing and outcome of infectious disease, personalized dosing guidelines in critically ill patients are highly needed. In this prospective observational population pharmacokinetic study we will evaluate if target attainment for antibiotics is reached in critically ill children with current dosing guidelines. Using these data, individualized dosing guidelines will be developed.
Approximately one third of all critically ill children develop infectious disease related complications. Mortality due to infections can be as high as 30-45%. In up to 41% of adult critically ill patients antimicrobial dosing recommendations are inadequate, as acute kidney injury, augmented renal clearance, inflammatory response and hypoalbuminaemia all contribute to variation in drug concentrations. This is an important reason for antibiotic treatment failure and emergence of resistance.
Data from adults cannot be directly extrapolated to children, due to developmental changes in the processes involved in drug disposition. Moreover, the interplay of age and critical illness is even more understudied. Hence, to optimize antibiotic dosing and outcome of infectious disease, personalized dosing guidelines in critically ill patients are highly needed.
In this prospective observational population pharmacokinetic study we will evaluate if target attainment for antibiotics is reached in critically ill children with current dosing guidelines. Using these data, individualized dosing guidelines will be developed.
Objectives:
To determine the population pharmacokinetics of antibiotics in critically ill pediatric patients to develop individualized dosing guidelines for antibiotics for this population.
Study design:
Observational study with minimal invasive procedures: population pharmacokinetic study.
Study population:
Critically ill children, admitted on the pediatric intensive care unit (PICU), receiving antibiotics.
Study parameters/endpoints:
Primary:
Secondary:
Exploratory:
1,923 studies on the registry are indexed under Critical Illness; 465 are open to participants now.
This study's planned enrollment of 200 is above the median of 130 across 883 observational studies indexed under Critical Illness.
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Critically ill children receiving antibiotics.
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Exclusion Criteria:
Pharmacokinetics
Drug: Pharmacokinetics
* Blood samples are drawn for pharmacokinetic properties of antibiotics during routine care treatment * Blood samples for relevant covariates of drug disposition (kidney function, liver enzymes, C-reactive protein (CRP), albumin) * Whole blood is stored for DNA analysis * Urine is drawn from catheter for more detailed estimation of glomerular filtration rate and drug metabolite analysis
Also known as: Antibiotics
Volume of distribution of antibiotics in critically ill children
Population mean value of volume of distribution of antibiotics during critical illness. Mean population volume of distribution will be derived from pooled data of antibiotic concentrations. Covariates of influence on volume of distribution will be incorporated within a population pharmacokinetic model.
Time frame: 14 days
Clearance of antibiotics in critically ill children
Population mean value of clearance of antibiotics during critical illness. Mean population clearance will be derived from pooled data of antibiotic concentrations. Covariates of influence on drug clearance will be incorporated within a population pharmacokinetic model.
Time frame: 14 days
Plan to share: No
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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