NIRS as a Continuous Noninvasive Monitoring System of Liver/Kidney Graft Perfusion

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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

Official Title
-----------------
Evaluation of NIRS as a Continuous Noninvasive Monitoring System of Liver/Kidney Graft Perfusion in the Early Postoperative Period in Pediatric Patients. Pilot Study

Conditions
-----------------
Liver Failure, Kidney Failure

Intervention / Treatment
-----------------
* Device: Near-InfraRed Spectroscopy (NIRS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pediatric patients admitted to our ICU for postoperative care after liver/kidney transplantation Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Near-InfraRed Spectroscopy (NIRS)<br>The NIRS Group will be monitored with the interventional system (NIRS) and with the standard one (ecodoppler) | Device: Near-InfraRed Spectroscopy (NIRS)<br>* NIRS is a non invasive monitoring system that enables assessment of tissue oxygenation through a quantitative estimation of haemoglobin oxygen-saturation within tissues.<br>* Other names: Somanetics INVOS® system;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hepatic/renal NIRS measurements and graft's artery resistance indices, as evaluated with ecodoppler |  | every hour from recovery time to 6 hours after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |