Pharmacokinetics of Ciprofloxacin in Critically Ill Patients (CAPOEIRA)
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| ClinicalTrials.gov Identifier: NCT03016845 |
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Recruitment Status :
Completed
First Posted : January 11, 2017
Last Update Posted : October 19, 2020
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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 |
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| Bacterial Infections |
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 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 |
- 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
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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 |
Inclusion Criteria:
- Patient is admitted to an ICU
- Subject is at least 18 years on the day of the first dosing
- Is managed with an arterial line or central venous catheter
- Is managed with an urinary catheter
- Is already treated with ciprofloxacin as part of routine clinical care
Exclusion Criteria:
- Has previously participated in this study
- Is on renal replacement therapy (RRT)
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
| Netherlands | |
| Ziekenhuis Gelderse Vallei | |
| Ede, Netherlands | |
| CWZ | |
| Nijmegen, Netherlands | |
| Radboudumc | |
| Nijmegen, Netherlands | |
| UMC Utrecht | |
| Utrecht, Netherlands | |
| Principal Investigator: | Roger Bruggemann | Radboud University |
Publications of Results:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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ciprofloxacin pharmacokinetics Intensive Care Unit |
Cystatin C CKD-EPI renal function |
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Bacterial Infections |