Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/04/2011
Date assigned
19/05/2011
Last edited
31/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maria Donnelly

ORCID ID

Contact details

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

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 measures

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

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

http://www.tcd.ie/

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

academic

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21816053

Publication citations

  1. 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.

Additional files

Editorial Notes