3D Contrast Enhanced UltraSound in perfusion studies of early renal transplants
| ISRCTN | ISRCTN44785771 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44785771 |
| Protocol serial number | 10201 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) |
| Funders | Northern Counties Kidney Research Fund (UK), Society and College of Radiographers (SCoR) (UK) |
- Submission date
- 29/06/2012
- Registration date
- 29/06/2012
- Last edited
- 28/02/2018
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Ben Stenberg
Scientific
Scientific
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
| Phone | +44 191 2336161 Ext: 26552 |
|---|---|
| ben.stenberg@nuth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised; Interventional; Design type: Diagnosis, Not specified |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | 3D Contrast Enhanced UltraSound in perfusion studies of early renal transplants: a non-randomised study |
| Study acronym | 3D CEUS |
| Study objectives | To assess the sensitivity of Three dimensional (3D) contrast enhanced ultrasound (CEUS) of detecting perfusion defects in kidney transplants immediately post-surgery. Also, determine any prognostic value from the haemodynamic factors of the contrast in predicting graft outcome. More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10201 |
| Ethics approval(s) | Newcastle & North Tyneside 2, 10/02/2011, ref: 11/H0907/1 |
| Health condition(s) or problem(s) studied | Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal |
| Intervention | Contrast enhanced ultrasound: Single examination using a 2.4mls injection of Sonovue contrast media. |
| Intervention type | Other |
| Primary outcome measure(s) | Perfusion defect rates using 99mTc-diethylenetriamine pentaacetic acid (DTPA) renogram |
| Key secondary outcome measure(s) | Graft viability up to 3 months post-op measured by serum results and histology reports. |
| Completion date | 31/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 105 |
| Key inclusion criteria | 1. All renal transplant patients that undergo surgery within the collection period for the study until study population is acheived (N=105) 2. Male & Female ; Lower Age Limit 18 years |
| Key exclusion criteria | 1. Any patient under 18 years of age 2. A pregnant patient and 3. Any patient excluded due to contraindications as listed in the manufacturers guidelines for the contrast media used |
| Date of first enrolment | 04/03/2011 |
| Date of final enrolment | 31/07/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Freeman Road
Newcastle upon Tyne
NE7 7DN
United Kingdom
NE7 7DN
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? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/01/2016: No publications found on PubMed.
28/02/2018: Added publication reference.
