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CAPOEIRA: Pharmacokinetics of Ciprofloxacin in Critically Ill Patients

Sponsor
Radboud University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03016845
Collaborator
Canisius-Wilhelmina Hospital (Other), UMC Utrecht (Other), Gelderse Vallei Hospital (Other), Tergooi Hospital (Other)
40
Enrollment
4
Locations
14.9
Actual Duration (Months)
10
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Pharmacokinetics of Ciprofloxacin in Critically Ill Patients - a Screening Study to Assess the Feasibility of Renal Function Markers to Predict Ciprofloxacin Clearance (CAPOEIRA)
    Actual Study Start Date :
    Jan 1, 2017
    Actual Primary Completion Date :
    Mar 1, 2018
    Actual Study Completion Date :
    Apr 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. model for estimation of renal function that most accurately predicts ciprofloxacin clearance [Day 1 and day 2]

      Full pharmacokinetic curves will be taken on Day 1 and Day 2

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ziekenhuis Gelderse Vallei Ede Netherlands
    2 CWZ Nijmegen Netherlands
    3 Radboudumc Nijmegen Netherlands
    4 UMC Utrecht Utrecht Netherlands

    Sponsors and Collaborators

    • Radboud University Medical Center
    • Canisius-Wilhelmina Hospital
    • UMC Utrecht
    • Gelderse Vallei Hospital
    • Tergooi Hospital

    Investigators

    • Principal Investigator: Roger Bruggemann, Radboud University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT03016845
    Other Study ID Numbers:
    • UMCN-AFK 16.07
    First Posted:
    Jan 11, 2017
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Radboud University Medical Center
    ciprofloxacin
    pharmacokinetics
    Intensive Care Unit
    Cystatin C
    CKD-EPI
    renal function
    Additional relevant MeSH terms:
    Bacterial Infections

    Study Results

    No Results Posted as of Oct 19, 2020