Evaluation of NIRS as a Continuous Noninvasive Monitoring System of Liver/Kidney Graft Perfusion in the Early Postoperative Period in Pediatric Patients. Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- hepatic/renal NIRS measurements and graft's artery resistance indices, as evaluated with ecodoppler
研究概览
简要总结
The aim of the investigators work is to describe the agreement between NIRS and ecodoppler, as monitoring systems of liver and kidney graft's perfusion in the immediate postoperative period in pediatric patients.
详细描述
This is an observational descriptive pilot study to explore the Somanetics INVOS® system performance. In this study the investigators will recruit a convenient number of patients, 15 patients, that will be admitted to our ICU after liver/kidney transplantation, in a 6 month period.
The Primary endpoint will be the correlation between hepatic/renal NIRS measurements and graft's artery resistance indices, as evaluated with ecodoppler.
The Secondary endpoints will be:
- The Correlation between NIRS measurements and biochemical indicators of graft function (NGAL for kidney transplantation and INR, SGOT/SGPT, bilirubin, lactate for liver transplantation)
- The Correlation between NIRS measurements and SvO2 values
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All pediatric patients admitted to our ICU for postoperative care after liver/kidney transplantation
排除标准
- •Obesity (BMI > 35)
- •Presence of a surgical plate over the graft
- •Impossibility of probe positioning, because of surgical wound, medication or drainage
- •Bilirubin level > 30 mg/dL
结局指标
主要结局
hepatic/renal NIRS measurements and graft's artery resistance indices, as evaluated with ecodoppler
时间窗: every hour from recovery time to 6 hours after extubation
次要结局
- hepatic/renal NIRS measurements and biochemical indicators of graft function: - NGAL for kidney transplantation - INR, SGOT/SGPT, bilirubin, lactate for liver transplantation(every hour until from recovery to 6 hours after extubation)
- hepatic/renal NIRS measurements and SvO2 values(every hour from recovery to 6 hours after extubation)
研究者
Mariella Enoc
Dirigente Medico A.R.C.O.
Bambino Gesù Hospital and Research Institute