Pharmacokinetics of Ciprofloxacin in Critically Ill Patients

Bacterial Infections Clinical Trial

— CAPOEIRA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03016845
• Other study ID #: UMCN-AFK 16.07
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: November 2017
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bacterial Infections

Locations

Country	Name	City	State
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	CWZ	Nijmegen
Netherlands	Radboudumc	Nijmegen
Netherlands	UMC Utrecht	Utrecht

Sponsors (5)

Lead Sponsor	Collaborator
Radboud University	Canisius-Wilhelmina Hospital, Gelderse Vallei Hospital, Tergooi Hospital, UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Gieling EM, Wallenburg E, Frenzel T, de Lange DW, Schouten JA, Ten Oever J, Kolwijck E, Burger DM, Pickkers P, Ter Heine R, Brüggemann RJM. Higher Dosage of Ciprofloxacin Necessary in Critically Ill Patients: A New Dosing Algorithm Based on Renal Function — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	model for estimation of renal function that most accurately predicts ciprofloxacin clearance	Full pharmacokinetic curves will be taken on Day 1 and Day 2	Day 1 and day 2

External Links

•   paper