Kidney Transplant Monitoring Using Near Infra-red Spectroscopy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02956018|
Recruitment Status : Completed
First Posted : November 4, 2016
Last Update Posted : February 15, 2018
Kidney transplant thrombosis (loss of blood flow) is responsible for up to 35% transplant failures in children. Detection of kidney transplant thrombosis currently relies on recognition of deterioration in parameters such as urine output and blood creatinine levels, which change relatively slowly. Confirmation is then required with an ultrasound scan. There is inherent delay in the above process, during which time some or all of the transplant kidney tissue can die, which can result in failure of the transplant.
Near infrared spectroscopy (NIRS) is a non-invasive technique used in continuous monitoring of oxygen levels in several organ systems including the brain, muscles, gut, liver and native kidneys. We hypothesise that NIRS can be applied to monitor kidney transplant blood flow in real time.
We aim to test the use of NIRS in detecting blood flow in established kidney transplants in children, and to compare it with ultrasound, the current gold standard measurement. Existing NIRS equipment would be used within its CE marked purpose measuring oxygen levels; this mechanistic study would extrapolate measured oxygen levels to determine blood flow. Participating children attending outpatient clinic for routine transplant ultrasound scans will have NIRs monitoring for a 10 minute period. NIRs data will be compared to a validated perfusion score from ultrasound images.
If this study is successful, NIRS could provide continuous monitoring of kidney transplant blood flow in the postoperative period, thus allowing immediate detection of blood flow problems. This has potential to reduce kidney transplant failures from thrombosis.
|Condition or disease|
|Kidney Transplant; Complications|
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Continuous Monitoring of Kidney Transplant Perfusion Using Near Infra-red Spectroscopy|
|Actual Study Start Date :||November 2016|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
- Correlation of NIRs perfusion data with Doppler ultrasound perfusion parameters assessed using a validated scale [ Time Frame: 6 months ]
- Quality of NIRS data obtained [ Time Frame: 6 months ]proportion of valid readings vs lost readings
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956018
|Great Ormond Street Hospital|
|London, United Kingdom, WC1N3JH|