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

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

Hemodynamic Indexes and Renal Perfusion: Indirect Evaluation of Blood Volume Using the Association Between ScvO2 and Urinary Electrolytes in Patients Undergoing Major Surgery.

The purpose of this study is to verify any existing relationship between mixed oxygen saturation (from central venous catheter) and urinary sodium, potassium, chloride in determining the volemic state and renal perfusion of patients undergoing major surgical interventions.

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing major surgery.

Description

Inclusion Criteria:

  • thoracic-abdominal major surgical operations
  • placing of a central venous catheter and urinary catheter
  • age 18-75
  • ASA class I-III

Exclusion Criteria:

  • age above 75 or under 18
  • ASA class IV
  • trauma, sepsis and/or heart-lung failure
  • liver transplantation
  • kidney transplantation
  • pre-existing renal failure
  • pregnant patients
  • patients unable to give their 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of mixed oxygen saturation in central venous blood (ScvO2) and three urinary electrolytes (sodium, potassium, chloride)
Time Frame: During the stay of the patient in the operating room (in average 6 hours) and the eventual stay in the post-surgery intensive care unit (in average 1 day)
During the stay of the patient in the operating room (in average 6 hours) and the eventual stay in the post-surgery intensive care unit (in average 1 day)

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliera di Padova

Investigators

  • Principal Investigator: Paolo Feltracco, M.D., Azienda Ospedaliera di Padova
  • Principal Investigator: Andrea Bortolato, M.D., Azienda Ospedaliera di Padova
  • Study Chair: Carlo Ori, Prof. M.D., University of 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 23, 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

  • 2660P

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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