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End - stage liver disease can cause many problems to the patients including fatigue, weakness,jaundice, confusion, abdominal pain and distension. Another important problem is the cardiovascular system (heart and blood vessels). There will be the impairment of heart function to pump blood to the distal part of the body. Blood vessels are also affected by the imbalance of chemical agents which are not detoxified by diseased liver, resulting in impairment of oxygen carrying capacity and tissue oxygen exchange. Mechanism of this process is still poorly understood.
This is a study about the peripheral vascular dysfunction by means of vascular occlusion test (VOT). Blood pressure cuff is inflated (to occlude the proximal vessels and induce distal part ischemia), then deflated and observing the distal tissue oxygenation (StO2)change by the probe (Near-infrared spectroscopy : NIRS) at the hand. From our knowledge, there is no study in patients undergoing liver transplantation.
The study investigator would like to observe the change in peripheral tissue oxygenation in different time points during the liver transplantation. We hypothesize that there is a change in microcirculatory function and StO2 in end-stage liver disease patients detected by VOT and NIRS.
End - stage liver disease patients scheduled for liver transplantation will be enrolled. They will receive normal standard of care. The VOT assessment using a non-invasive, integrated research device (InspectraTM StO2 Vascular Occlusion test (VOT) Research Device Hutchinson Corp Minn, MN, USA) and 15 mm Inspectra thenar sensor probe. An integrated blood pressure cuff is placed on the right arm and inflated to a pressure sufficient to produce arterial inflow occlusion (50mmHg above systolic pressure). The cuff remains inflated until a StO2 value of 40% is achieved. During the inflation and deflation, various StO2 parameters are measured and recorded at designed time point.
Specific VOT parameters of interest:
Data collection
Demographic data: a)age, b)sex, c)diagnosis, d)Model of End-stage Liver Disease (MELD) score, Body Mass Index (BMI)
Clinical parameter : the investigator will collect clinical data including VOT parameters (from above), hemodynamics parameter, chemical parameters and medications used in specific time frame :
time frame
hemodynamics : SpO2 (Pulse oxygen saturation), MAP (mean arterial pressure), HR (heart rate), CVP (Central venous pressure), PAP (Pulmonary artery pressure), CI (Cardiac output index), PCWP (Pulmonary artery wedge pressure), SVRI (Systemic vascular resistance index), PVRI (Pulmonary vascular resistance index), temperature
chemical : Hb, Platelets, INR (international normalized ratio) (PT : Prothrombin time), PTT (partial thromboplastin time), Lactate, base excess
Medications : Volatile agents, Vasopressors (Concentration at recorded time points)
Then we will compare the dynamic changes of StO2 parameters in different time points (as mentioned) and compare to the hemodynamics and chemical parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the end-stage liver disease patients | the end-stage liver disease scheduled for liver transplantation |
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| Measure | Description | Time Frame |
|---|---|---|
| the significant changes in StO2 between anhepatic and reperfusion phase of the end-stage liver disease patient undergoing liver transplantation | Our data measured will be included only during the operation and at skin closure can reflect early postoperative period. | compare the change of StO2 during different phase of the liver transplantation (base line, pre-anhepatic phase, anhepatic phase, re-perfusion phase and at skin closure) |
| Measure | Description | Time Frame |
|---|---|---|
| dynamic changes in StO2 during liver transplantation with possible correlation with hemodynamic or chemical parameters in different time points | from previous study indicates that new liver start its metabolic function well right after the vascular connection complete. So, the investigator want to analyze the correlation between the dynamic StO2 changes during operative period | preoperative for baseline data, intraoperative (during different phase of liver transplantation) and finish data record at skin closure time) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients suffering from end-stage liver disease scheduled for liver transplantation
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| Name | Affiliation | Role |
|---|---|---|
| Achal Dhir, MD | Western University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, London Health Science Center | London | Ontario | N6A 5A5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7927273 | Background | Groszmann RJ. Hyperdynamic circulation of liver disease 40 years later: pathophysiology and clinical consequences. Hepatology. 1994 Nov;20(5):1359-63. No abstract available. | |
| 12480559 | Background | Helmy A, Newby DE, Jalan R, Johnston NR, Hayes PC, Webb DJ. Nitric oxide mediates the reduced vasoconstrictor response to angiotensin II in patients with preascitic cirrhosis. J Hepatol. 2003 Jan;38(1):44-50. doi: 10.1016/s0168-8278(02)00319-7. |
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| ID | Term |
|---|---|
| D058625 | End Stage Liver Disease |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| 2218394 | Background | Okumura H, Aramaki T, Katsuta Y, Terada H, Satomura K, Akaike M, Sekiyama T. Regional differences in peripheral circulation between upper and lower extremity in patients with cirrhosis. Scand J Gastroenterol. 1990 Sep;25(9):883-9. doi: 10.3109/00365529008997608. |
| 18276031 | Background | Caraceni P, Dazzani F, Salizzoni E, Domenicali M, Zambruni A, Trevisani F, Bernardi M. Muscle circulation contributes to hyperdynamic circulatory syndrome in advanced cirrhosis. J Hepatol. 2008 Apr;48(4):559-66. doi: 10.1016/j.jhep.2007.12.016. Epub 2008 Jan 31. |
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| 19912533 | Background | Thomson SJ, Cowan ML, Forton DM, Clark SJ, Musa S, Grounds M, Rahman TM. A study of muscle tissue oxygenation and peripheral microcirculatory dysfunction in cirrhosis using near infrared spectroscopy. Liver Int. 2010 Mar;30(3):463-71. doi: 10.1111/j.1478-3231.2009.02157.x. Epub 2009 Nov 16. |
| 1617992 | Background | Steib A, Freys G, Gohard R, Curzola U, Ravanello J, Lutun P, Boudjema K, Otteni JC. Tissue oxygenation during liver transplantation. Crit Care Med. 1992 Jul;20(7):977-83. doi: 10.1097/00003246-199207000-00013. |
| 20128030 | Background | Al-Hamoudi WK, Alqahtani S, Tandon P, Ma M, Lee SS. Hemodynamics in the immediate post-transplantation period in alcoholic and viral cirrhosis. World J Gastroenterol. 2010 Feb 7;16(5):608-12. doi: 10.3748/wjg.v16.i5.608. |
| 2667599 | Background | Shelly MP, Dixon JS, Park GR. The pharmacokinetics of midazolam following orthotopic liver transplantation. Br J Clin Pharmacol. 1989 May;27(5):629-33. doi: 10.1111/j.1365-2125.1989.tb03428.x. |
| 9265907 | Background | Hickman PE, Potter JM, Pesce AJ. Clinical chemistry and post-liver-transplant monitoring. Clin Chem. 1997 Aug;43(8 Pt 2):1546-54. |