|
ISRCTN
|
ISRCTN44660887
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Cumulative EFfects of Intravenous Treatments in Cystic Fibrosis
|
|
Scientific title
|
Cumulative EFfects of Intravenous Treatments in Cystic Fibrosis: a cross-sectional observational study
|
|
Acronym
|
CEFIT CF
|
|
Serial number at source
|
09025
|
|
Study hypothesis
|
Cumulative exposure to intravenous treatments causes decreased glomerular filtration rate and impaired hearing in paediatric cystic fibrosis patients.
|
|
Lay summary
|
|
|
Ethics approval
|
North Nottinghamshire Research Ethics Committee approved on the 25th August 2009 (ref: 09/H0407/23)
|
|
Study design
|
Observational cross-sectional cohort study
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Cystic fibrosis
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
01/11/2009
|
|
Anticipated end date
|
01/11/2011
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please contact Andrew Payle, the study administrator, at Andrew.Prayle@nottingham.ac.uk to request a patient information sheet
|
|
Target number of participants
|
80
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
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.
|
|
Sources of funding
|
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-1207-15025)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Alan
Smyth
|
|
Address
|
Child Health
E Floor East Block
Queens Medical Centre
Derby Rd
|
|
City/town
|
Nottingham
|
|
Zip/Postcode
|
NG7 2UH
|
|
Country
|
United Kingdom
|
|
Sponsor
|
The University of Nottingham (UK)
|
|
Address
|
Research Innovation Services
King's Meadow Campus
Lenton Lane
|
|
City/town
|
Nottingham
|
|
Zip/Postcode
|
NG7 2NR
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.nottingham.ac.uk/
|
|
Date applied
|
30/10/2009
|
|
Last edited
|
12/01/2010
|
|
Date ISRCTN assigned
|
12/01/2010
|
