Cystic fibrosis Nutritional, Metabolic, Endocrine Cystic fibrosis
Conditions
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
Sponsors
The University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed