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

Kidney Failure Clinical Trial

— NIRS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02343016
• Other study ID #: 781_OPBG_2014
• Status: Terminated
• Start date: February 2015
• Est. completion date: June 2015

Study information

• Verified date: May 2019
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Kidney Failure
• Liver Failure
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Italy	Bambino Gesù Hospital and Research Institute	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Mariella Enoc	Medtronic - MITG

Country where clinical trial is conducted

Italy, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Ghobrial RM, Farmer DG, Amersi F, Busuttil RW. Advances in pediatric liver and intestinal transplantation. Am J Surg. 2000 Nov;180(5):328-34. Review. — View Citation

Hendrickson RJ, Karrer FM, Wachs ME, Slater K, Bak TE, Kam I. Pediatric liver transplantation. Curr Opin Pediatr. 2004 Jun;16(3):309-13. Review. — View Citation

Jöbsis FF. Noninvasive, infrared monitoring of cerebral and myocardial oxygen sufficiency and circulatory parameters. Science. 1977 Dec 23;198(4323):1264-7. — View Citation

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. — View Citation

Leone M, Blidi S, Antonini F, Meyssignac B, Bordon S, Garcin F, Charvet A, Blasco V, Albanèse 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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. Epub 2005 Apr 1. — View Citation

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. — View Citation

Spada M, Riva S, Maggiore G, Cintorino D, Gridelli B. Pediatric liver transplantation. World J Gastroenterol. 2009 Feb 14;15(6):648-74. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	hepatic/renal NIRS measurements and SvO2 values		every hour from recovery to 6 hours after extubation