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临床试验/NCT02956018
NCT02956018已完成不适用

Continuous Monitoring of Kidney Transplant Perfusion Using Near Infra-red Spectroscopy

Great Ormond Street Hospital for Children NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Correlation of NIRs perfusion data with Doppler ultrasound perfusion parameters assessed using a validated scale

研究概览

简要总结

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.

详细描述

The purpose of this mechanistic pilot study is to determine whether existing NIRS equipment, used within its intended CE marked purpose measuring tissue oxygenation, can reliably determine blood flow in established kidney transplants.

Objectives

  1. To compare NIRS to the current gold standard measure of kidney transplant perfusion, Doppler ultrasound, in established kidney transplants in children
  2. To determine the practicality of using NIRS to measure perfusion in children with established kidney transplants

Outcomes Primary Outcome • Correlation of NIRs perfusion data with Doppler ultrasound perfusion parameters assessed using a validated scale.

Secondary outcomes

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • patients with transplant wound complications

结局指标

主要结局

Correlation of NIRs perfusion data with Doppler ultrasound perfusion parameters assessed using a validated scale

时间窗: 6 months

次要结局

  • Quality of NIRS data obtained(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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