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

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

Study information

Study designObservational cross-sectional cohort study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeTreatment
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 titleCumulative EFfects of Intravenous Treatments in Cystic Fibrosis: a cross-sectional observational study
Study acronymCEFIT CF
Study objectivesCumulative 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) studiedCystic fibrosis
InterventionAs 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 typeOther
Primary outcome measure1. 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 measures1. 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 date01/11/2009
Completion date31/12/2012

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit5 Years
SexBoth
Target number of participants80
Key inclusion criteria1. 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 criteria1. 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 enrolment01/11/2009
Date of final enrolment31/12/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Sponsor information

The University of Nottingham (UK)
University/education

Research Innovation Services
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom

Website http://www.nottingham.ac.uk/
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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