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Evaluation of Hemodynamics and Amount of Blood Flowing Through the Kidneys During Liver Transplant by Measuring Some Physiological Substances in Blood and Urines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01650116
Recruitment Status : Unknown
Verified November 2014 by Dr. Paolo Feltracco, Azienda Ospedaliera di Padova.
Recruitment status was:  Recruiting
First Posted : July 26, 2012
Last Update Posted : November 20, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Paolo Feltracco, Azienda Ospedaliera di Padova

Brief Summary:
The purpose of this study is to verify any existing relationship between urinary parameters (such as excretion of sodium, chlorine, urinary partial CO2 pressure [PuCO2]) and general volemic indicators (such as PiCCO, ScvO2, O2 delivery) during liver transplant.

Condition or disease
Hypovolemia During Liver Transplantation Renal Hypoperfusion During Liver Transplantation

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Sodium Urinary Excretion, Chlorine Urinary Excretion, Urinary Partial CO2 Pressure as Renal Perfusion Indicators During Liver Transplant. Comparison With Other Polemic State Indicators (Such as PiCCO, ScvO2, O2 Delivery).
Study Start Date : July 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Determination of hemodynamic indicators (PiCCO, ScvO2, O2-delivery) and three urinary analytes (sodium, chloride, CO2 partial pressure) [ Time Frame: During the stay of the patient in the operating room (in average 8 hours) and the subsequent stay in the post-surgery intensive care unit (in average 5 days) ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing liver transplantation
Criteria

Inclusion Criteria:

  • surgery for liver transplantation
  • age 18-75
  • ASA class I-III

Exclusion Criteria:

  • age above 75 or under 18
  • ASA class IV
  • pre-existing renal failure
  • pregnant patients
  • patients unable to give written consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650116


Contacts
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Contact: Paolo Feltracco, M.D. +393493410225 paolofeltracco@inwind.it
Contact: Andrea Bortolato, M.D. +393316169933 freeandrea.b@libero.it

Locations
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Italy
Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Contact    +390498218285      
Contact    +390498218286      
Principal Investigator: Paolo Feltracco, M.D.         
Principal Investigator: Andrea Bortolato, M.D.         
Sub-Investigator: Daniele Bonvicini, M.D.         
Sub-Investigator: Tommaso Tonetti, M.D.         
Sponsors and Collaborators
Azienda Ospedaliera di Padova
Investigators
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Study Chair: Carlo Ori, Prof. M.D. Università degli Studi di Padova - Azienda Ospedaliera di Padova
Principal Investigator: Paolo Feltracco, M.D. Azienda Ospedaliera di Padova
Principal Investigator: Andrea Bortolato, M.D. Azienda Ospedaliera di Padova
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Responsible Party: Dr. Paolo Feltracco, Principal Investigator, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier: NCT01650116    
Other Study ID Numbers: 2661P
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014
Keywords provided by Dr. Paolo Feltracco, Azienda Ospedaliera di Padova:
hypovolemia
renal hypoperfusion
liver transplantation
sodium
chloride
PuCO2
ScvO2
PiCCO
O2-delivery
hemodynamic indexes
Additional relevant MeSH terms:
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Hypovolemia
Pathologic Processes