NCT02343016

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Mariella Enoc · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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

Conditions

• Liver Failure
• Kidney Failure

Interventions

Type	Name	Description
DEVICE	Near-InfraRed Spectroscopy (NIRS)	NIRS is a non invasive monitoring system that enables assessment of tissue oxygenation through a quantitative estimation of haemoglobin oxygen-saturation within tissues.

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-01-21
• Last updated: 2019-05-22

Locations

1 site across 1 country: Italy