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

November 19, 2014 updated by: Dr. Paolo Feltracco, Azienda Ospedaliera di Padova

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).

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Padova, Italy, 35128
        • Recruiting
        • Azienda Ospedaliera di Padova
        • Contact:
          • Phone Number: +390498218285
        • Contact:
          • Phone Number: +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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing liver transplantation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera di Padova

Investigators

  • Study Chair: Carlo Ori, Prof. M.D., Universita 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 24, 2012

First Submitted That Met QC Criteria

July 25, 2012

First Posted (Estimate)

July 26, 2012

Study Record Updates

Last Update Posted (Estimate)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2661P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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