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

May 21, 2019 updated by: Mariella Enoc

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00165
        • Bambino Gesù Hospital and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All pediatric patients admitted to our ICU for postoperative care after liver/kidney transplantation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Near-InfraRed Spectroscopy (NIRS)
The NIRS Group will be monitored with the interventional system (NIRS) and with the standard one (ecodoppler)
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.
Other Names:
  • Somanetics INVOS® system

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
hepatic/renal NIRS measurements and biochemical indicators of graft function: - NGAL for kidney transplantation - INR, SGOT/SGPT, bilirubin, lactate for liver transplantation
Time Frame: every hour until from recovery to 6 hours after extubation
every hour until from recovery to 6 hours after extubation
hepatic/renal NIRS measurements and SvO2 values
Time Frame: every hour from recovery to 6 hours after extubation
every hour from recovery to 6 hours after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mariella Enoc

Collaborators

Medtronic - MITG

Investigators

  • Study Director: Sergio Picardo, MD, Bambino Gesù Hospital and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

January 15, 2015

First Posted (Estimate)

January 21, 2015

Study Record Updates

Last Update Posted (Actual)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 781_OPBG_2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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