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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02343016
Acronym
NIRS
Enrollment
15
Registered
2015-01-21
Start date
2015-02-28
Completion date
2015-06-30
Last updated
2019-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Liver Failure

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

Interventions

NIRS is a non invasive monitoring system that enables assessment of tissue oxygenation through a quantitative estimation of haemoglobin oxygen-saturation within tissues.

Sponsors

Medtronic - MITG
CollaboratorINDUSTRY
Mariella Enoc
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
hepatic/renal NIRS measurements and graft's artery resistance indices, as evaluated with ecodopplerevery hour from recovery time to 6 hours after extubation

Secondary

MeasureTime frame
hepatic/renal NIRS measurements and biochemical indicators of graft function: - NGAL for kidney transplantation - INR, SGOT/SGPT, bilirubin, lactate for liver transplantationevery hour until from recovery to 6 hours after extubation
hepatic/renal NIRS measurements and SvO2 valuesevery hour from recovery to 6 hours after extubation

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026