To study ciprofloxacin pharmacokinetics in patients who are critically ill and undergoing continuous dialysis

ISRCTN ISRCTN52722850
DOI https://doi.org/10.1186/ISRCTN52722850
EudraCT/CTIS number 2004-002195-42
Secondary identifying numbers 300704 CT Number: CT900/425/1
Submission date
14/04/2011
Registration date
19/05/2011
Last edited
31/01/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Maria Donnelly
Scientific

Department of Intensive Care Medicine
The Adelaide and Meath Hospital
Dublin Incorporating the National Children's Hospital (AMNCH)
Tallaght
Dublin
24
Ireland

Study information

Study designOpen, prospective, observational pharmacokinetic study
Primary study designObservational
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAn evaluation of ciprofloxacin pharmacokinetics in critically ill patients undergoing continuous veno-venous haemodiafiltration
Study objectivesUnder 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(s)St James's Hospital and the Adelaide and Meath Hospital, Dublin, Incorporating the National Children's Hospital Joint Ethics Committee Reference Number 041008/7804
Health condition(s) or problem(s) studiedPatients on dialysis
Intervention1. 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 typeOther
Primary outcome measureTo obtain reliable estimates of ciprofloxacin pharmacokinetic parameters for patients in intensive care unit (ICU) on Continuous veno-venous hemodiafiltration (CVVHDF)
Secondary outcome measuresTo describe achieved pharmacodynamic parameters in these patients
Overall study start date01/01/2005
Completion date31/10/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants7 = 3 female, 4 male
Key inclusion criteria1. Aged over 18
2. Requiring Continuous Veno Venous Hemodiafiltration (CVVHDF)
3. Requiring ciprofloxacin therapy
Key exclusion criteria1. Aged less than 18
2. Patient / relative consent denied
Date of first enrolment01/01/2005
Date of final enrolment31/10/2006

Locations

Countries of recruitment

  • Ireland

Study participating centre

Department of Intensive Care Medicine
Dublin
24
Ireland

Sponsor information

Trinity College Dublin (Ireland)
University/education

c/o Prof Owen Corrigan
School of Pharmacy and Pharmaceutical Sciences
Trinity College Dublin
Dublin
2
Ireland

Website http://www.tcd.ie/
ROR logo "ROR" https://ror.org/02tyrky19

Funders

Funder type

University/education

Trinity College Dublin (Ireland)
Private sector organisation / Universities (academic only)
Alternative name(s)
Coláiste na Tríonóide, Baile Átha Cliath, TCD
Location
Ireland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 04/08/2011 Yes No