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

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ClinicalTrials.gov Identifier: NCT02343016
Recruitment Status : Terminated (due to a decision by the research team not to continuos the study)
First Posted : January 21, 2015
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Mariella Enoc, Bambino Gesù Hospital and Research Institute

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.

Condition or disease Intervention/treatment
Liver Failure Kidney Failure Device: Near-InfraRed Spectroscopy (NIRS)

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

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Actual Study Start Date : February 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

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 Name: Somanetics INVOS® system




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. hepatic/renal NIRS measurements and SvO2 values [ Time Frame: every hour from recovery to 6 hours after extubation ]

Biospecimen Retention:   Samples Without DNA
  • Blood count
  • Coagulation: INR, PT,PTT, ATIII, fibrinogen
  • Electrolytes
  • Albumine, proteins
  • Liver function specific markers: GOT/GPT, total and direct bilirubin, urea nitrogen, lactic acid
  • Renal function specific markers: NGAL, creatinine, urea nitrogen


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All pediatric patients admitted to our ICU for postoperative care after liver/kidney transplantation.
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

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): NCT02343016


Locations
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Italy
Bambino Gesù Hospital and Research Institute
Rome, Italy, 00165
Sponsors and Collaborators
Mariella Enoc
Medtronic - MITG
Investigators
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Study Director: Sergio Picardo, MD Bambino Gesù Hospital and Research Institute

Publications:

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Responsible Party: Mariella Enoc, Dirigente Medico A.R.C.O., Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT02343016     History of Changes
Other Study ID Numbers: 781_OPBG_2014
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Renal Insufficiency
Liver Failure
Hepatic Insufficiency
Kidney Diseases
Urologic Diseases
Liver Diseases
Digestive System Diseases