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

Sponsor

Azienda Ospedaliera di Padova (Other)

Overall Status

Unknown status

CT.gov ID

NCT01650116

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Hypovolemia During Liver Transplantation Renal Hypoperfusion During Liver Transplantation

Study Design

Study Type:

Observational

Anticipated 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 :

Jul 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Outcome Measures

Primary Outcome Measures

Determination of hemodynamic indicators (PiCCO, ScvO2, O2-delivery) and three urinary analytes (sodium, chloride, CO2 partial pressure) [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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Azienda Ospedaliera di Padova	Padova		Italy	35128

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
Principal Investigator: Andrea Bortolato, M.D., Azienda Ospedaliera di Padova