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due to a decision by the research team not to continuos the study
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| Name | Class |
|---|---|
| Medtronic - MITG | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Near-InfraRed Spectroscopy (NIRS) | The NIRS Group will be monitored with the interventional system (NIRS) and with the standard one (ecodoppler) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| hepatic/renal NIRS measurements and graft's artery resistance indices, as evaluated with ecodoppler | every hour from recovery time to 6 hours after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All pediatric patients admitted to our ICU for postoperative care after liver/kidney transplantation.
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| Name | Affiliation | Role |
|---|---|---|
| Sergio Picardo, MD | Bambino Gesù Hospital and Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bambino Gesù Hospital and Research Institute | Rome | 00165 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19222089 | Background | 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. | |
| 15167019 | Background | 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. |
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| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D007674 | Kidney Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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|
| every hour from recovery to 6 hours after extubation |
| 11137682 | Background | 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. |
| 929199 | Background | 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. |
| 7896615 | Background | 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. |
| 22129547 | Background | 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. |
| 10485597 | Background | 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. |
| 21388077 | Background | Moerman A, Wouters P. Near-infrared spectroscopy (NIRS) monitoring in contemporary anesthesia and critical care. Acta Anaesthesiol Belg. 2010;61(4):185-94. |
| 18185128 | Background | 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. |
| 15803294 | Background | 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. |
| 18184248 | Background | 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. |
| 11014921 | Background | 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. |
| 16539638 | Background | 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. |
| 11511955 | Background | 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. |
| 19602965 | Background | 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. |
| 18687043 | Background | 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. |
| 19775036 | Background | 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. |
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |