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Kidney Transplant Monitoring Using Near Infra-red Spectroscopy

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ClinicalTrials.gov Identifier: NCT02956018
Recruitment Status : Completed
First Posted : November 4, 2016
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

Brief Summary:

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

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Correlation of NIRs perfusion data with Doppler ultrasound perfusion parameters assessed using a validated scale [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Quality of NIRS data obtained [ Time Frame: 6 months ]
    proportion of valid readings vs lost readings



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
50 children with established kidney transplants undergoing follow up at Great Ormond Street Children's Hospital
Criteria

Inclusion Criteria:

  • Children aged 1 - 18 years who received kidney transplants at Great Ormond Street Children's Hospital.

Exclusion Criteria:

  • patients with transplant wound complications

Information from the National Library of Medicine

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


Locations
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United Kingdom
Great Ormond Street Hospital
London, United Kingdom, WC1N3JH
Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust

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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02956018     History of Changes
Other Study ID Numbers: 16HM06
213885 ( Other Identifier: IRAS )
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Great Ormond Street Hospital for Children NHS Foundation Trust:
children