Clinical trial NCT02343016: NIRS as a Continuous Noninvasive Monitoring System of Liver/Kidney Graft Perfusion
Official title: Evaluation of NIRS as a Continuous Noninvasive Monitoring System of Liver/Kidney Graft Perfusion in the Early Postoperative Period in Pediatric Patients. Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Failure
Kidney Failure
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2015-01-21
Enrollment: 15
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All pediatric patients admitted to our ICU for postoperative care after liver/kidney transplantation.

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

Eligibility criteria: 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

Primary outcomes:
measure: hepatic/renal NIRS measurements and graft's artery resistance indices, as evaluated with ecodoppler
timeFrame: every hour from recovery time to 6 hours after extubation
Secondary outcomes:
measure: hepatic/renal NIRS measurements and biochemical indicators of graft function: - NGAL for kidney transplantation - INR, SGOT/SGPT, bilirubin, lactate for liver transplantation
timeFrame: every hour until from recovery to 6 hours after extubation
measure: hepatic/renal NIRS measurements and SvO2 values
timeFrame: every hour from recovery to 6 hours after extubation
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Bambino Gesù Hospital and Research Institute
Study officials:
affiliation: Bambino Gesù Hospital and Research Institute
name: Sergio Picardo, MD
role: STUDY_DIRECTOR
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