RecruitingNCT03636464
Pharmacokinetics of Antibiotics in Patients Undergoing Renal Replacement Therapies
Pharmacokinetics and Deposition of Commonly Prescribed Antibiotics in Hospitalized Critically Ill Patients Undergoing Renal Replacement Therapies
Sponsor
Cleveland Clinic Abu Dhabi
Enrollment
200 participants
Start Date
Apr 1, 2018
Study Type
OBSERVATIONAL
Summary
The study is aiming to describe the pharmacokinetic and pharmacodynamic profile of intravenous meropenem, ertapenem, cefepime, colistin, Ceftazidime/Avibactam , Ceftolozane/Tazobactam , and piperacillin/tazobactam in the plasma and determine how much is removed by Renal Replacement Therapies to ensure adequate dosing
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- Adults > 18 year old
- Prescribed meropenem, ertapenem, cefepime, colistin, Ceftazidime/Avibactam , Ceftolozane/Tazobactam , or piperacillin/tazobactam for treatment of infection as part of standard medical care
- Administered meropenem, ertapenem, cefepime, colistin, Ceftazidime/Avibactam , Ceftolozane/Tazobactam ,or piperacillin/tazobactam while on renal replacement therapy (IHD or CRRT) or renal replacement therapy started while on any of these antibiotics
- Patients with hemoglobin > 70 g/L without blood transfusion in the past 24 hours
- Informed consent given by patient, next of kin or legally authorized representative
Exclusion Criteria10
- Less than 18 years of age
- Pregnant females
- Body mass index < 18 or > 35 kg/m2
- Presence of anemia (defined as hemoglobin < 70 g/L), thrombocytopenia, or leukopenia as defined by hematocrit, platelet, or white blood cell count < 75% of the lower limit of normal
- Concomitant receipt of another cephalosporin interfering with assay
- Participants likely to require surgical interventions during the study period if the surgery would interfere with dosing intervals or affect sampling process
- Protected patients; prisoners, patients with HIV, patients with physical or mental disabilities, psychiatric patients.
- Patients with documented life-threatening allergy (i.e anaphylaxis, angioedema) to any of the study drugs or their class.
- Patients with conditions known to significantly affect PK; (i.e. severe burn, significant ascites, spinal cord injury and cystic fibrosis)
- Any other reason felt by the investigators to potentially affect the outcomes of the study
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Interventions
OTHERBlood collection
Pharmacokinetics
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03636464