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Trial record 92 of 2660 for:    bilirubin

Influence of Hyperbilirubinaemia on Two Different Near Infrared Spectroscopy Devices (NIRS_GREFFE)

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ClinicalTrials.gov Identifier: NCT03945942
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:
Protocol Near infrared spectroscopy liver transplants: comparison of two monitoring of Near infrared spectroscopy in pediatric liver transplant.

Condition or disease Intervention/treatment Phase
Liver Transplant; Complications Device: Near infrared spectroscopy with INVOS device Device: Near infrared spectroscopy with Foresight device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Influence of Hyperbilirubinaemia on Foresight and INVOS Oximetry Values in Pediatric Hepatic Transplantation
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Pediatric liver transplant patients
Using somatic and cerebral Near infrared spectroscopy devices
Device: Near infrared spectroscopy with INVOS device
somatic and cerebral oximetry by INVOS in pediatric liver transplantation

Device: Near infrared spectroscopy with Foresight device
somatic and cerebral oximetry with Foresight device in pediatric liver transplantation




Primary Outcome Measures :
  1. influence of chromophores such as bilirubin on oximetry values provided by two different devices [ Time Frame: From Day 0 of surgery until arrival at pediatric intensive care unit (up to 12 hours) ]
    measure of oximetry values by two different devices at different time points in function of serum bilirubin levels



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945942


Contacts
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Contact: MAGASICH-AIROLA Natalia, MD +3227648034 natalia.magasich@uclouvain.be

Locations
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Belgium
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Natalia MAGASICH-AIROLA, MD    +3227648034    natalia.magasich@uclouvain.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Natalia MAGASICH-AIROLA, MD natalia.magasich@uclouvain.be

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03945942     History of Changes
Other Study ID Numbers: 2018/07NOV/413
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperbilirubinemia
Pathologic Processes