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

Terminated

• Conditions: Kidney Failure; Liver Failure
• Interventions: Device: Near-InfraRed Spectroscopy (NIRS)

• Registration Number: NCT02343016
• Lead Sponsor: Mariella Enoc

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

Study Timeline

• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2015-01-15
• Study First Posted: 2015-01-21
• Study Start: 2015-02
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Near-InfraRed Spectroscopy (NIRS)	Near-InfraRed Spectroscopy (NIRS)	The NIRS Group will be monitored with the interventional system (NIRS) and with the standard one (ecodoppler)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Bambino Gesù Hospital and Research Institute; 🇮🇹 Rome, Italy