NCT02343016

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 22, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

November 10, 2014

Last Update Submit

May 21, 2019

Conditions

Liver FailureKidney Failure

Outcome Measures

Primary Outcomes (1)

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

    every hour from recovery time to 6 hours after extubation

Secondary Outcomes (2)

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

    every hour until from recovery to 6 hours after extubation

  • hepatic/renal NIRS measurements and SvO2 values

    every hour from recovery to 6 hours after extubation

Study Arms (1)

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)

Interventions

Near-InfraRed Spectroscopy (NIRS)DEVICE

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

Also known as: Somanetics INVOS® system
Near-InfraRed Spectroscopy (NIRS)

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bambino Gesù Hospital and Research Institute

Rome, 00165, Italy

Location

Related Publications (17)

  • 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.

    PMID: 19222089BACKGROUND

  • 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.

    PMID: 15167019BACKGROUND

  • 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.

    PMID: 11137682BACKGROUND

  • 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.

    PMID: 929199BACKGROUND

  • 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.

    PMID: 7896615BACKGROUND

  • 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.

    PMID: 22129547BACKGROUND

  • 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.

    PMID: 10485597BACKGROUND

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

    PMID: 21388077BACKGROUND

  • 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.

    PMID: 18185128BACKGROUND

  • 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.

    PMID: 15803294BACKGROUND

  • 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.

    PMID: 18184248BACKGROUND

  • 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.

    PMID: 11014921BACKGROUND

  • 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.

    PMID: 16539638BACKGROUND

  • 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.

    PMID: 11511955BACKGROUND

  • 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.

    PMID: 19602965BACKGROUND

  • Mulier KE, Skarda DE, Taylor JH, Myers DE, McGraw MK, Gallea BL, Beilman GJ. Near-infrared spectroscopy in patients with severe sepsis: correlation with invasive hemodynamic measurements. Surg Infect (Larchmt). 2008 Oct;9(5):515-9. doi: 10.1089/sur.2007.091.

    PMID: 18687043BACKGROUND

  • Nanas S, Gerovasili V, Renieris P, Angelopoulos E, Poriazi M, Kritikos K, Siafaka A, Baraboutis I, Zervakis D, Markaki V, Routsi C, Roussos C. Non-invasive assessment of the microcirculation in critically ill patients. Anaesth Intensive Care. 2009 Sep;37(5):733-9. doi: 10.1177/0310057X0903700516.

    PMID: 19775036BACKGROUND

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

MeSH Terms

Conditions

Liver FailureRenal Insufficiency

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Sergio Picardo, MD

    Bambino Gesù Hospital and Research Institute

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dirigente Medico A.R.C.O.

Study Record Dates

First Submitted

November 10, 2014

First Posted

January 21, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 22, 2019

Record last verified: 2019-05

Locations

IT(1)