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Pharmacokinetics of Ciprofloxacin in Critically Ill Patients (CAPOEIRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03016845
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Canisius-Wilhelmina Hospital
UMC Utrecht
Gelderse Vallei Hospital
Tergooi Hospital
Information provided by (Responsible Party):
Radboud University

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
Bacterial Infections

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.

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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 : January 1, 2017
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests




Primary Outcome Measures :
  1. model for estimation of renal function that most accurately predicts ciprofloxacin clearance [ Time Frame: Day 1 and day 2 ]
    Full pharmacokinetic curves will be taken on Day 1 and Day 2


Biospecimen Retention:   Samples Without DNA
plasma samples for determination of ciprofloxacin and cystatin C Urine for measuring 24h creatinine cleaurance


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients receiving ciprofloxacin for treating a suspected or proven bacterial infection at the ICU will be included.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016845


Locations
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Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
CWZ
Nijmegen, Netherlands
Radboudumc
Nijmegen, Netherlands
UMC Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
Radboud University
Canisius-Wilhelmina Hospital
UMC Utrecht
Gelderse Vallei Hospital
Tergooi Hospital
Investigators
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Principal Investigator: Roger Bruggemann Radboud University
Additional Information:
paper  This link exits the ClinicalTrials.gov site

Publications of Results:
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03016845    
Other Study ID Numbers: UMCN-AFK 16.07
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
ciprofloxacin
pharmacokinetics
Intensive Care Unit
Cystatin C
CKD-EPI
renal function
Additional relevant MeSH terms:
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Bacterial Infections