Liver Disease Clinical Trial
Official title:
Evaluation of a New Calibrated Pulse Wave Analysis Method(EV1000™/volumeView™) for Cardiac Output Monitoring in Adult Liver Transplantation
Verified date | December 2015 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Institutional Review Board |
Study type | Interventional |
The investigators are trying to evaluate the agreement of cardiac output measurements taken using the specific thermistor-tipped arterial catheter ( the VolumeView ™ catheter) and the EV1000 ™ monitoring platform ( Edward lifesciences, Irvine, CA, USA) with measurements taken using continuous pulmonary artery thermodilution cardiac output monitoring during orthotopic liver transplantation.
Status | Completed |
Enrollment | 28 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: subjects undergoing living donor liver transplantation during the study period subjects older than 20yrs who can give informed consent Exclusion Criteria: those who are confirmed moderate severe aortic regurgitation by echocardiography those with infection on cannulation site |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Arnal D, Garutti I, Perez-Peña J, Olmedilla L, Tzenkov IG. Radial to femoral arterial blood pressure differences during liver transplantation. Anaesthesia. 2005 Aug;60(8):766-71. — View Citation
Bendjelid K, Giraud R, Siegenthaler N, Michard F. Validation of a new transpulmonary thermodilution system to assess global end-diastolic volume and extravascular lung water. Crit Care. 2010;14(6):R209. doi: 10.1186/cc9332. Epub 2010 Nov 23. — View Citation
Bendjelid K, Marx G, Kiefer N, Simon TP, Geisen M, Hoeft A, Siegenthaler N, Hofer CK. Performance of a new pulse contour method for continuous cardiac output monitoring: validation in critically ill patients. Br J Anaesth. 2013 Oct;111(4):573-9. doi: 10.1 — View Citation
Biancofiore G, Critchley LA, Lee A, Bindi L, Bisà M, Esposito M, Meacci L, Mozzo R, DeSimone P, Urbani L, Filipponi F. Evaluation of an uncalibrated arterial pulse contour cardiac output monitoring system in cirrhotic patients undergoing liver surgery. Br — View Citation
Biancofiore G, Critchley LA, Lee A, Yang XX, Bindi LM, Esposito M, Bisà M, Meacci L, Mozzo R, Filipponi F. Evaluation of a new software version of the FloTrac/Vigileo (version 3.02) and a comparison with previous data in cirrhotic patients undergoing live — View Citation
Feltracco P, Biancofiore G, Ori C, Saner FH, Della Rocca G. Limits and pitfalls of haemodynamic monitoring systems in liver transplantation surgery. Minerva Anestesiol. 2012 Dec;78(12):1372-84. Epub 2012 Aug 3. Review. — View Citation
Galluccio ST, Chapman MJ, Finnis ME. Femoral-radial arterial pressure gradients in critically ill patients. Crit Care Resusc. 2009 Mar;11(1):34-8. — View Citation
Kiefer N, Hofer CK, Marx G, Geisen M, Giraud R, Siegenthaler N, Hoeft A, Bendjelid K, Rex S. Clinical validation of a new thermodilution system for the assessment of cardiac output and volumetric parameters. Crit Care. 2012 May 30;16(3):R98. doi: 10.1186/ — View Citation
Kim YK, Shin WJ, Song JG, Jun IG, Kim HY, Seong SH, Hwang GS. Comparison of stroke volume variations derived from radial and femoral arterial pressure waveforms during liver transplantation. Transplant Proc. 2009 Dec;41(10):4220-8. doi: 10.1016/j.transpro — View Citation
Sakka SG, Kozieras J, Thuemer O, van Hout N. Measurement of cardiac output: a comparison between transpulmonary thermodilution and uncalibrated pulse contour analysis. Br J Anaesth. 2007 Sep;99(3):337-42. Epub 2007 Jul 4. — View Citation
Tsai YF, Su BC, Lin CC, Liu FC, Lee WC, Yu HP. Cardiac output derived from arterial pressure waveform analysis: validation of the third-generation software in patients undergoing orthotopic liver transplantation. Transplant Proc. 2012 Mar;44(2):433-7. doi — View Citation
Uemura K, Kawada T, Inagaki M, Sugimachi M. A minimally invasive monitoring system of cardiac output using aortic flow velocity and peripheral arterial pressure profile. Anesth Analg. 2013 May;116(5):1006-17. doi: 10.1213/ANE.0b013e31828a75bd. Epub 2013 M — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cardiac output | L/minute, 28 participants, EV1000 by femoral artery, Pulmonary artery thermodilution | intraoperative | No |
Secondary | systemic vascular resistance | dyne s/cm5,28 participants, EV1000 by femoral artery, Pulmonary artery thermodilution | intraoperative | No |
Secondary | stroke volume variability | %, 28 participants, EV1000 by femoral artery, Pulmonary artery thermodilution | during surgery every 10 minute, event time for example, anhepatic, liver in, reperfusion, using inotropics, changing ventilator setting | No |
Secondary | stroke volume | ml, 28 participants, EV1000 by femiral artery, Pulmonary artery thermodilution | intraoperative | No |
Secondary | ejection fraction | %, 28 participants, EV1000 by femoral artery, Pulmonary artery thermodilution | intraoperative | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02798861 -
Controlled Attenuation Parameter (CAP) in Liver Allografts
|
||
Completed |
NCT01968395 -
Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure
|
Phase 4 | |
Completed |
NCT01437969 -
Pharmacogenomics Study on IL28B Genetic Variants in Italian Patients With HCV Infection naïve to Treatment.
|
||
Recruiting |
NCT00155376 -
Intravenous-Morphine and Glucagon-Usage Enhanced MR Cholangiography
|
Phase 4 | |
Recruiting |
NCT00172705 -
Quantitative Diagnosis of Fatty Liver by Dual Energy CT Technique
|
N/A | |
Completed |
NCT04185454 -
Estimation of Minimum Efficacy Daily Dose of Jarlsberg Cheese
|
N/A | |
Completed |
NCT02506335 -
Liver Function Measured by HepQuant-SHUNT in the Prediction of Outcomes in Patients With Heart Disease
|
Early Phase 1 | |
Completed |
NCT02520609 -
Dynamic Post-Prandial Metabolism in Patients With Non-Alcoholic Fatty Liver Disease
|
||
Completed |
NCT01988753 -
Non-invasive Biomarkers of Fibrosis in Pediatric Liver Diseases
|
||
Completed |
NCT01970904 -
Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
|
N/A | |
Terminated |
NCT00741117 -
Conjugated Hyperbilirubinemia and Pulse Oximetry
|
N/A | |
Enrolling by invitation |
NCT01483248 -
Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis
|
Phase 1/Phase 2 | |
Completed |
NCT00245830 -
Ischemic Preconditioning of Liver in Cadaver Donors
|
N/A | |
Completed |
NCT00074386 -
Kidney and Liver Transplantation in People With HIV
|
N/A | |
Completed |
NCT02329821 -
Change of Lactate Concentration During Hartmann Solution Infusion for Hepatic Resection
|
N/A | |
Completed |
NCT01303549 -
Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients
|
Phase 4 | |
Completed |
NCT01650181 -
Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis
|
Phase 4 | |
Completed |
NCT00799851 -
A Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection for Esophageal Varices
|
Phase 4 | |
Completed |
NCT00058890 -
Gabapentin to Treat Itch in Patients With Liver Disease
|
Phase 3 | |
Completed |
NCT02311348 -
Comparing Pain in Patients Undergoing Percutaneous Versus Transjugular Techniques of Liver Biopsy
|
N/A |