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Pharmacokinetics of Ciprofloxacin in Critically Ill Patients

Pharmacokinetics of Ciprofloxacin in Critically Ill Patients - a Screening Study to Assess the Feasibility of Renal Function Markers to Predict Ciprofloxacin Clearance (CAPOEIRA)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03016845
Acronym
CAPOEIRA
Enrollment
40
Registered
2017-01-11
Start date
2017-01-01
Completion date
2018-04-01
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections

Keywords

ciprofloxacin, pharmacokinetics, Intensive Care Unit, Cystatin C, CKD-EPI, renal function

Brief summary

Optimal understanding of ciprofloxacin pharmacokinetics in critically ill patients is lacking resulting in large variation of achieved exposure and possible inadequate therapy. The investigators hypothesize that drug dosing based on CKD-EPIcr-cys provides a useful method to individualize and optimize therapy for ciprofloxacin and eventually improve outcome. In a multi-centre, observational, open-label study the investigators aim to define : the model for estimation of renal function that most accurately predicts ciprofloxacin clearance in critically ill patients.

Detailed description

Correct estimation of glomerular filtration rate (GFR) is necessary in critically ill patients in order to asses renal function. GFR is subsequently used to derive and appropriate drug dosing of renally excreted drugs and warrant adequate dose adaptations. It is known that estimation of GFR based on creatinine clearance is not precise, especially in populations with altered muscle mass or instable renal function, such as the Intensive Care Unit (ICU) population. The use of combined filtration markers together, cystatin C and creatinine, can improve precision in estimating GFR (eGFR). Studies confirmed that eGFR based on both creatinine and cystatin C is more precise than eGFR creatinine or eGFR cystatin C. The equation based on both creatinine and cystatin C, the Chronic Kidney Disease Epidemiology Collaboration creatinine-cystatin C (CKD-EPIcr-cys), may therefore improve eGFR and thus drug dosing in ICU patients, a population that does not reach PK/PD targets frequently. So far little is known about drug dosing based on CKD-EPIcr-cys. Currently optimal understanding of ciprofloxacin pharmacokinetics in critically ill patients is lacking, resulting in large variation of achieved exposure and possible inadequate therapy. The investigators hypothesize that drug dosing based on CKD-EPIcr-cys provides a useful method to individualize and optimize therapy for ciprofloxacin and eventually improve outcome. In a multi-centre, observational, open-label study the investigators aim to define the model for estimation of renal function that most accurately predicts ciprofloxacin clearance in critically ill patients.

Interventions

None listed

Sponsors

Canisius-Wilhelmina Hospital
CollaboratorOTHER
UMC Utrecht
CollaboratorOTHER
Gelderse Vallei Hospital
CollaboratorOTHER
Tergooi Hospital
CollaboratorOTHER
Radboud University Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patient is admitted to an ICU 2. Subject is at least 18 years on the day of the first dosing 3. Is managed with an arterial line or central venous catheter 4. Is managed with an urinary catheter 5. Is already treated with ciprofloxacin as part of routine clinical care

Exclusion criteria

1. Has previously participated in this study 2. Is on renal replacement therapy (RRT)

Design outcomes

Primary

MeasureTime frameDescription
model for estimation of renal function that most accurately predicts ciprofloxacin clearanceDay 1 and day 2Full pharmacokinetic curves will be taken on Day 1 and Day 2

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026