Additional identifiers
EudraCT number
2004-002195-42
ClinicalTrials.gov number
Protocol/serial number
300704 CT Number: CT900/425/1
Study information
Scientific title
An evaluation of ciprofloxacin pharmacokinetics in critically ill patients undergoing continuous veno-venous haemodiafiltration
Acronym
Study hypothesis
Under dosing of antibiotics has enabled the genesis of resistant strains and this is particularly an issue with fluoroquinolones. Altered drug pharmacokinetics, due to disease, results in variable antimicrobial drug clearance in critically ill patients (antibiotic regimens are often developed on the basis of drug disposition in non-critically ill volunteers) and further complicates the selection of appropriate dosing schedules for these patients. The goal of ciprofloxacin therapy is to maximise the 24 hour Area Under the Curve/Minimum Inhibitory Concentration and the peak/MIC ratios. A number of papers have highlighted the requirement for a re-evaluation of currently recommended antimicrobial dosage regimens for critically ill patients.
Ethics approval
St James's Hospital and the Adelaide and Meath Hospital, Dublin, Incorporating the National Children's Hospital Joint Ethics Committee Reference Number 041008/7804
Study design
Open, prospective, observational pharmacokinetic study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Patients on dialysis
Intervention
1. Timed serum samples were collected during each dosage interval and ultrafiltrate during 7 dosage intervals (1 per patient)
2. Effluent fluid was collected for the entire dosage interval
3. The volume of each hourly batch was recorded and a 40ml sample was taken for analysis
4. Aliquots from each sample were analysed for ciprofloxacin concentration and for creatinine determination
5. Total ciprofloxacin concentrations in serum and effluent were measured by a HPLC method
6. Serum concentrations, from an indwelling arterial cannula, were measured immediately before the infusion was started, immediately after the infusion finished and at 2,3,4,6,8 and 12 hours post infusion where the dosage interval was 12 hours
7. When the prescribed dosage interval was 24hr samples were also taken at 18 and 24hrs
8. Exact sampling times were recorded
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
To obtain reliable estimates of ciprofloxacin pharmacokinetic parameters for patients in intensive care unit (ICU) on Continuous veno-venous hemodiafiltration (CVVHDF)
Secondary outcome measures
To describe achieved pharmacodynamic parameters in these patients
Overall trial start date
01/01/2005
Overall trial end date
31/10/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged over 18
2. Requiring Continuous Veno Venous Hemodiafiltration (CVVHDF)
3. Requiring ciprofloxacin therapy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
7 = 3 female, 4 male
Participant exclusion criteria
1. Aged less than 18
2. Patient / relative consent denied
Recruitment start date
01/01/2005
Recruitment end date
31/10/2006
Locations
Countries of recruitment
Ireland
Trial participating centre
Department of Intensive Care Medicine
Dublin
24
Ireland
Sponsor information
Organisation
Trinity College Dublin (Ireland)
Sponsor details
c/o Prof Owen Corrigan
School of Pharmacy and Pharmaceutical Sciences
Trinity College Dublin
Dublin
2
Ireland
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Trinity College Dublin (Ireland)
Alternative name(s)
Coláiste na Tríonóide, Baile Átha Cliath, TCD
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Ireland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21816053
Publication citations
-
Results
Spooner AM, Deegan C, D'Arcy DM, Gowing CM, Donnelly MB, Corrigan OI, An evaluation of ciprofloxacin pharmacokinetics in critically ill patients undergoing continuous veno-venous haemodiafiltration., BMC Clin Pharmacol, 2011, 11, 11, doi: 10.1186/1472-6904-11-11.