Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
09025
Study information
Scientific title
Cumulative EFfects of Intravenous Treatments in Cystic Fibrosis: a cross-sectional observational study
Acronym
CEFIT CF
Study hypothesis
Cumulative exposure to intravenous treatments causes decreased glomerular filtration rate and impaired hearing in paediatric cystic fibrosis patients.
On 14/02/2012 the overall trial end date was changed from 01/11/2011 to 31/12/2012.
Ethics approval
North Nottinghamshire Research Ethics Committee, 25/08/2009, ref: 09/H0407/23
Study design
Observational cross-sectional cohort study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact Andrew Payle, the study administrator, at Andrew.Prayle@nottingham.ac.uk to request a patient information sheet
Condition
Cystic fibrosis
Intervention
As an observational study, there is only one arm. After consent, each patient has a Chromium 51 EDTA based glomerular filtration rate (GFR test). A hearing assessment is performed, which consists of a combination of pure tone audiogram, a tympanogram, and distortion product otoacoustic emissions (DPOAE). Blood and urine samples are taken for biomarkers of kidney injury. A saliva sample is taken for genetic analysis. These interventions will take place in hospital over a 5-hour visit. The cumulative lifetime exposure to aminoglycoside and other intravenous treatments is calculated retrospectively by reviewing the patient notes.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. The prevalence of chronic kidney disease (GFR less than 80 ml/min/1.73 square metres)
2. The prevalence of hearing impairment
3. The association between cumulative lifetime exposure to intravenous aminoglycosides and GFR will be explored with multiple regression, after adjustment for potential confounders
Both primary and secondary outcomes will be assessed when all patients have completed the study protocol.
Secondary outcome measures
1. Cystatin C in the blood
2. Agreement between cystatin C based formula for GFR and measured GFR (using Cr51EDTA)
3. Genetic analysis methods will depend upon the numbers of participants who have poor kidney function or hearing impairment. Thus after preliminary data regarding these are available, a plan for genetic analyses will be proposed.
Both primary and secondary outcomes will be assessed when all patients have completed the study protocol.
Overall trial start date
01/11/2009
Overall trial end date
31/12/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Cystic fibrosis (defined as a positive sweat test, or genetic PLUS clinical features, or positive screening test, or CF in sibling)
2. Participant or participants legally acceptable representative must be able to give informed consent
3. Aged 5 years and over, both males and females
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Intravenous antibiotics in the last 2 weeks
2. Participation in another research project which excludes the patient from this study
3. Poor patient prognosis, and the clinician feels that this or other difficult family circumstances would make taking part in the research inappropriate
4. A postive pregnancy test
Recruitment start date
01/11/2009
Recruitment end date
31/12/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
The University of Nottingham (UK)
Sponsor details
Research Innovation Services
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-1207-15025)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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