Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/10/2009
Date assigned
12/01/2010
Last edited
28/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alan Smyth

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09025

Study information

Scientific title

Cumulative EFfects of Intravenous Treatments in Cystic Fibrosis: a cross-sectional observational study

Acronym

CEFIT CF

Study hypothesis

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

North Nottinghamshire Research Ethics Committee, 25/08/2009, ref: 09/H0407/23

Study design

Observational cross-sectional cohort study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Treatment

Patient 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

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/11/2009

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

80

Participant 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

Recruitment start date

01/11/2009

Recruitment end date

31/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

The University of Nottingham (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-1207-15025)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes