To study ciprofloxacin pharmacokinetics in patients who are critically ill and undergoing continuous dialysis
| ISRCTN | ISRCTN52722850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52722850 |
| Clinical Trials Information System (CTIS) | 2004-002195-42 |
| Protocol serial number | 300704 CT Number: CT900/425/1 |
| Sponsor | Trinity College Dublin (Ireland) |
| Funder | Trinity College Dublin (Ireland) |
- 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
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
| Primary study design | Observational |
|---|---|
| Study design | Open, prospective, observational pharmacokinetic study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | An evaluation of ciprofloxacin pharmacokinetics in critically ill patients undergoing continuous veno-venous haemodiafiltration |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
To obtain reliable estimates of ciprofloxacin pharmacokinetic parameters for patients in intensive care unit (ICU) on Continuous veno-venous hemodiafiltration (CVVHDF) |
| Key secondary outcome measure(s) |
To describe achieved pharmacodynamic parameters in these patients |
| Completion date | 31/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 7 |
| Key inclusion criteria | 1. Aged over 18 2. Requiring Continuous Veno Venous Hemodiafiltration (CVVHDF) 3. Requiring ciprofloxacin therapy |
| Key exclusion criteria | 1. Aged less than 18 2. Patient / relative consent denied |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/10/2006 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Department of Intensive Care Medicine
Dublin
24
Ireland
24
Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
