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

Mariella Enoc

Status: Terminated

Conditions: Kidney Failure; Liver Failure

Treatments: Device: Near-InfraRed Spectroscopy (NIRS)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02343016

781_OPBG_2014

Details and patient eligibility

About

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.

Full 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

Enrollment: 15 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

Near-InfraRed Spectroscopy (NIRS)

Description:

The NIRS Group will be monitored with the interventional system (NIRS) and with the standard one (ecodoppler)

Treatment:

Device: Near-InfraRed Spectroscopy (NIRS)