Cumulative EFfects of Intravenous Treatments in Cystic Fibrosis

ISRCTN	ISRCTN44660887
DOI	https://doi.org/10.1186/ISRCTN44660887
Protocol serial number	09025
Sponsor	The University of Nottingham (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-1207-15025)

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

Child Health
E Floor East Block
Queens Medical Centre
Derby Rd
Nottingham
NG7 2UH
United Kingdom

Study information

Primary study design	Observational
Study design	Observational cross-sectional cohort study
Secondary study design	Cross sectional study
Study type	Participant 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(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.
Key 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.
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Queens Medical Centre

Nottingham
NG7 2UH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/12/2017: No publications found, verifying study status with principal investigator.