Back to resultsInfluence of Hyperbilirubinaemia on Two Different Near Infrared Spectroscopy Devices (NIRS_GREFFE)
Primary Purpose
Liver Transplant; Complications
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Near infrared spectroscopy with INVOS device
Near infrared spectroscopy with Foresight device
Sponsored by
About this trial
This is an interventional other trial for Liver Transplant; Complications
Eligibility Criteria
Inclusion Criteria:
- Pediatric patients 0 to 18 years, with a liver transplant with living donor program of our institution
- Free, informed and written consent signed by the investigator or employees and by the legal guardians of minor patients in the days preceding the procedure
Exclusion Criteria:
- refusal of the patient or his parents to consent
- known brain or Neurological pathology
Sites / Locations
- Cliniques Universitaires Saint-Luc
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pediatric liver transplant patients
Arm Description
Using somatic and cerebral Near infrared spectroscopy devices
Outcomes
Primary Outcome Measures
influence of chromophores such as bilirubin on oximetry values provided by two different devices
measure of oximetry values by two different devices at different time points in function of serum bilirubin levels
Secondary Outcome Measures
Full Information
NCT ID
NCT03945942
First Posted
March 4, 2019
Last Updated
March 17, 2021
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT03945942
Brief Title
Influence of Hyperbilirubinaemia on Two Different Near Infrared Spectroscopy Devices
Acronym
NIRS_GREFFE
Official Title
Influence of Hyperbilirubinaemia on Foresight and INVOS Oximetry Values in Pediatric Hepatic Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Protocol Near infrared spectroscopy liver transplants: comparison of two monitoring of Near infrared spectroscopy in pediatric liver transplant.
Detailed Description
Hyperbilirubinaemia may interfere with oximetry values as measured by Near Infrared Spectroscopy devices. The number of wave lengths used by different devices can influence the oximetry values in adult patients. This has never been demonstrated in children with hyperbilirubinaemia scheduled for elective liver transplantation.The study will compare cerebral and somatic oximetry values measured by two different Near infrared spectroscopy devices (FORESIGHT and INVOS) and analyse the influence of bilirubin levels on these differences.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplant; Complications
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pediatric liver transplant patients
Arm Type
Other
Arm Description
Using somatic and cerebral Near infrared spectroscopy devices
Intervention Type
Device
Intervention Name(s)
Near infrared spectroscopy with INVOS device
Intervention Description
somatic and cerebral oximetry by INVOS in pediatric liver transplantation
Intervention Type
Device
Intervention Name(s)
Near infrared spectroscopy with Foresight device
Intervention Description
somatic and cerebral oximetry with Foresight device in pediatric liver transplantation
Primary Outcome Measure Information:
Title
influence of chromophores such as bilirubin on oximetry values provided by two different devices
Description
measure of oximetry values by two different devices at different time points in function of serum bilirubin levels
Time Frame
From Day 0 of surgery until arrival at pediatric intensive care unit (up to 12 hours)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pediatric patients 0 to 18 years, with a liver transplant with living donor program of our institution
Free, informed and written consent signed by the investigator or employees and by the legal guardians of minor patients in the days preceding the procedure
Exclusion Criteria:
refusal of the patient or his parents to consent
known brain or Neurological pathology
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalia MAGASICH-AIROLA, MD
Organizational Affiliation
natalia.magasich@uclouvain.be
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Influence of Hyperbilirubinaemia on Two Different Near Infrared Spectroscopy Devices
We'll reach out to this number within 24 hrs