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Liver FailureNIRSNCT02343016

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

An observational study of Liver Failure and Kidney Failure, run by Mariella Enoc at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Liver Failure, Kidney Failure
What is being tested?
Near-InfraRed Spectroscopy (NIRS)
Type of treatment
Medical device
How many people
15 participants
Where
1 siteItaly
Study dates
Feb 2015to Jun 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Bambino Gesù Hospital and Research Institute

    Rome, 00165

Other trials in Italy

About this study

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

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.

Read the 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
Being tested
Near-InfraRed Spectroscopy (NIRS)
Medical subject headings
Liver Failure, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Near-InfraRed Spectroscopy (NIRS)Device

    Also called Somanetics INVOS® system

    NIRS is a non invasive monitoring system that enables assessment of tissue oxygenation through a quantitative estimation of haemoglobin oxygen-saturation within tissues.

Study groups in NCT02343016
Study groupRoleWhat they receive
Near-InfraRed Spectroscopy (NIRS)The NIRS Group will be monitored with the interventional system (NIRS) and with the standard one (ecodoppler)
Receives: Device: Near-InfraRed Spectroscopy (NIRS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hepatic/renal NIRS measurements and graft's artery resistance indices, as evaluated with ecodoppler

    Measured: every hour from recovery time to 6 hours after extubation

Secondary outcomes (2)

  1. hepatic/renal NIRS measurements and biochemical indicators of graft function: - NGAL for kidney transplantation - INR, SGOT/SGPT, bilirubin, lactate for liver transplantation

    Measured: every hour until from recovery to 6 hours after extubation

  2. hepatic/renal NIRS measurements and SvO2 values

    Measured: every hour from recovery to 6 hours after extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionJun 2015
  4. Study completionJun 2015

Why it stopped: due to a decision by the research team not to continuos the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02343016
Sponsor's protocol ID
781_OPBG_2014
Acronym
NIRS
Status last verified
May 2019
First submitted
10 Nov 2014
Last updated
22 May 2019
Results posted
No
Data monitoring committee
No

Publications

  • Spada M, Riva S, Maggiore G, Cintorino D, Gridelli B. Pediatric liver transplantation. World J Gastroenterol. 2009 Feb 14;15(6):648-74. doi: 10.3748/wjg.15.648.

    PubMed 19222089

  • Hendrickson RJ, Karrer FM, Wachs ME, Slater K, Bak TE, Kam I. Pediatric liver transplantation. Curr Opin Pediatr. 2004 Jun;16(3):309-13. doi: 10.1097/01.mop.0000127160.82531.77.

    PubMed 15167019

  • Ghobrial RM, Farmer DG, Amersi F, Busuttil RW. Advances in pediatric liver and intestinal transplantation. Am J Surg. 2000 Nov;180(5):328-34. doi: 10.1016/s0002-9610(00)00550-x.

    PubMed 11137682

  • Jobsis FF. Noninvasive, infrared monitoring of cerebral and myocardial oxygen sufficiency and circulatory parameters. Science. 1977 Dec 23;198(4323):1264-7. doi: 10.1126/science.929199.

    PubMed 929199

  • Mancini DM, Bolinger L, Li H, Kendrick K, Chance B, Wilson JR. Validation of near-infrared spectroscopy in humans. J Appl Physiol (1985). 1994 Dec;77(6):2740-7. doi: 10.1152/jappl.1994.77.6.2740.

    PubMed 7896615

  • Ghanayem NS, Wernovsky G, Hoffman GM. Near-infrared spectroscopy as a hemodynamic monitor in critical illness. Pediatr Crit Care Med. 2011 Jul;12(4 Suppl):S27-32. doi: 10.1097/PCC.0b013e318221173a.

    PubMed 22129547

  • Beilman GJ, Groehler KE, Lazaron V, Ortner JP. Near-infrared spectroscopy measurement of regional tissue oxyhemoglobin saturation during hemorrhagic shock. Shock. 1999 Sep;12(3):196-200. doi: 10.1097/00024382-199909000-00005.

    PubMed 10485597

  • Moerman A, Wouters P. Near-infrared spectroscopy (NIRS) monitoring in contemporary anesthesia and critical care. Acta Anaesthesiol Belg. 2010;61(4):185-94.

    PubMed 21388077

  • Johnson BA, Chang AC. Near-infrared spectroscopy and tissue oxygenation: the unremitting quest for the holy grail. Pediatr Crit Care Med. 2008 Jan;9(1):123-4. doi: 10.1097/01.PCC.0000299375.17007.BC. No abstract available.

    PubMed 18185128

  • Nagdyman N, Fleck T, Schubert S, Ewert P, Peters B, Lange PE, Abdul-Khaliq H. Comparison between cerebral tissue oxygenation index measured by near-infrared spectroscopy and venous jugular bulb saturation in children. Intensive Care Med. 2005 Jun;31(6):846-50. doi: 10.1007/s00134-005-2618-0. Epub 2005 Apr 1.

    PubMed 15803294

  • Nagdyman N, Ewert P, Peters B, Miera O, Fleck T, Berger F. Comparison of different near-infrared spectroscopic cerebral oxygenation indices with central venous and jugular venous oxygenation saturation in children. Paediatr Anaesth. 2008 Feb;18(2):160-6. doi: 10.1111/j.1460-9592.2007.02365.x.

    PubMed 18184248

  • El-Desoky AE, Jiao LR, Havlik R, Habib N, Davidson BR, Seifalian AM. Measurement of hepatic tissue hypoxia using near infrared spectroscopy: comparison with hepatic vein oxygen partial pressure. Eur Surg Res. 2000;32(4):207-14. doi: 10.1159/000008766.

    PubMed 11014921

  • Mitsuta H, Ohdan H, Fudaba Y, Irei T, Tashiro H, Itamoto T, Asahara T. Near-infrared spectroscopic analysis of hemodynamics and mitochondrial redox in right lobe grafts in living-donor liver transplantation. Am J Transplant. 2006 Apr;6(4):797-805. doi: 10.1111/j.1600-6143.2006.01247.x.

    PubMed 16539638

  • Fortune PM, Wagstaff M, Petros AJ. Cerebro-splanchnic oxygenation ratio (CSOR) using near infrared spectroscopy may be able to predict splanchnic ischaemia in neonates. Intensive Care Med. 2001 Aug;27(8):1401-7. doi: 10.1007/s001340100994.

    PubMed 11511955

  • Leone M, Blidi S, Antonini F, Meyssignac B, Bordon S, Garcin F, Charvet A, Blasco V, Albanese J, Martin C. Oxygen tissue saturation is lower in nonsurvivors than in survivors after early resuscitation of septic shock. Anesthesiology. 2009 Aug;111(2):366-71. doi: 10.1097/ALN.0b013e3181aae72d.

    PubMed 19602965

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Failure and Kidney Failure, run by Mariella Enoc at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: due to a decision by the research team not to continuos the study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02343016, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.

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