Examination of Pyelonephritis In Children with magnetic resonance imaging (MRI)

ISRCTN	ISRCTN36325312
DOI	https://doi.org/10.1186/ISRCTN36325312
Secondary identifying numbers	NL32462.094.10

Submission date: 01/04/2011
Registration date: 19/07/2011
Last edited: 30/11/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Miss Carine Martins Jarnalo
Scientific

Wilhelminalaan 12
Amsterdam
1800 AM
Netherlands

Study information

Study design	Validating cohort study
Primary study design	Observational
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Examination of Pyelonephritis In Children with magnetic resonance imaging (MRI): a cohort study
Study acronym	EPIC
Study hypothesis	Magnetic resonance imaging (MRI) can be used as an alternative to dimercaptosuccinic acid (DMSA) for the diagnosis of pyelonephritis in children.
Ethics approval(s)	METC Noord Holland approved on 30th November 2010, ref: NL32462.094.10
Condition	Pyelonephritis
Intervention	MR-imaging is performed within 8 hours of the DMSA scan. MR examinations of the abdomen and pelvis are performed with the patient in supine position and with a body phased-array coil (better signal-to-noise ratio) on a 1.5-T system (Magnetom Avanto, Siemens, Erlangen, Germany). All MR examinations are performed using a set protocol. Single-shot images (if possible with breath-hold) are made to provide a motion-insensitive image, even in the presence of severe motion. The total examination time is less than 20 min for the MRI in total. The parents can accompany the patient during the examination. If necessary a nurse from the paediatric department may also accompany the patient.
Intervention type	Other
Primary outcome measure	1. The sensitivity, specificity, positive and negative predictive value and inter observer agreement of MRI in diagnosing acute pyelonephritis as compared to the reference standard. 1.1. The MRI findings will be compared to the findings at imaging of the standard diagnostic work-up that preceded MRI. The diagnostic value of specific MRI characteristics for pyelonephritis will be calculated. The value of diffusion-weighted imaging (DWI) will be analysed.
Secondary outcome measures	1. To determine whether MR-diffusion weighted imaging (DWI) has additional value in the imaging of pyelonephritis 2. To determine whether MRI scanning can differentiate acute pyelonephritis from renal scarring
Overall study start date	04/04/2011
Overall study end date	04/04/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	18 Years
Sex	Both
Target number of participants	80
Participant inclusion criteria	1. Patients from 0 to 18 years, with: 1.1. Acute pyelonephritis, defined as a urinary tract infection (UTI) with a body temperature above 38 °C 1.2. Suspicion of acute pyelonephritis, suggested by symptoms of a UTI and flank pain 2. For young children (under the age of 1 year and in the pre-verbal phase) other clinical symptoms can suggest pyelonephritis. This is bacteriuria with either fever, vomitus, lethargia, anorexia, abdominal pain, pollakisuria or flank pain 3. Outside the study setting, the patient would have received a dimercaptosuccinic acid (DMSA) scan 4. Patients, or a legal representative, must be able to give informed consent, and the consent must be obtained prior to the MR Imaging and DMSA scanning
Participant exclusion criteria	1. Previous diagnosis of pyelonephritis 2. All contra-indications for undergoing MRI 3. A psychiatric, addictive, or any disorder that compromises the ability to give truly informed consent for participation in this study
Recruitment start date	04/04/2011
Recruitment end date	04/04/2013

Locations

Countries of recruitment

Netherlands

Study participating centre

Wilhelminalaan 12

Amsterdam
1800 AM
Netherlands

Sponsor information

Foreest Medical School (Netherlands)
University/education

26 Juni Arcadialaan 14
Amsterdam
1813 KN
Netherlands

Website	http://www.foreestmedicalschool.nl
"ROR"	https://ror.org/00bc64s87

Funders

Funder type

University/education

The Foreest institute (Netherlands)

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