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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

This study is currently recruiting participants.
Verified July 2012 by Azienda Ospedaliera di Padova
Sponsor:
Information provided by (Responsible Party):
Dr. Paolo Feltracco, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier:
NCT01650116
First received: July 24, 2012
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Hypovolemia During Liver Transplantation
Renal Hypoperfusion During Liver Transplantation

Study Type: Observational
Study Design: 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).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera di Padova:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650116

Contacts
Contact: Paolo Feltracco, M.D. +393493410225 paolofeltracco@inwind.it
Contact: Stefania Barbieri, M.D. +393479812611 stefibarbieri@libero.it

Locations
Italy
Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Contact     +390498218285        
Contact     +390498218286        
Principal Investigator: Carlo Ori, Prof. M.D.            
Principal Investigator: Paolo Feltracco, M.D.            
Sub-Investigator: Andrea Bortolato, M.D.            
Sub-Investigator: Stefania Barbieri, M.D.            
Sub-Investigator: Helmut Galligioni, M.D.            
Sub-Investigator: Daniele Bonvicini, M.D.            
Sub-Investigator: Tommaso Tonetti, student            
Sponsors and Collaborators
Azienda Ospedaliera di Padova
Investigators
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
  More Information

No publications provided

Responsible Party: Dr. Paolo Feltracco, Principal Investigator, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier: NCT01650116     History of Changes
Other Study ID Numbers: 2661P
Study First Received: July 24, 2012
Last Updated: July 25, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera di Padova:
hypovolemia
renal hypoperfusion
liver transplantation
sodium
chloride
 PuCO2
ScvO2
PiCCO
O2-delivery
hemodynamic indexes

Additional relevant MeSH terms:
Hypovolemia
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013