Cumulative EFfects of Intravenous Treatments in Cystic Fibrosis
| ISRCTN | ISRCTN44660887 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44660887 |
| Secondary identifying numbers | 09025 |
- Submission date
- 30/10/2009
- Registration date
- 12/01/2010
- Last edited
- 20/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alan Smyth
Scientific
Scientific
Child Health
E Floor East Block
Queens Medical Centre
Derby Rd
Nottingham
NG7 2UH
United Kingdom
Study information
| Study design | Observational cross-sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant 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 |
| Scientific title | Cumulative EFfects of Intravenous Treatments in Cystic Fibrosis: a cross-sectional observational study |
| Study acronym | CEFIT CF |
| Study objectives | 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(s) | North Nottinghamshire Research Ethics Committee, 25/08/2009, ref: 09/H0407/23 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2009 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2009 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
The University of Nottingham (UK)
University/education
University/education
Research Innovation Services
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom
| Website | http://www.nottingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-1207-15025)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
20/12/2017: No publications found, verifying study status with principal investigator.
