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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by Dr. Paolo Feltracco, Azienda Ospedaliera di Padova.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Dr. Paolo Feltracco, Azienda Ospedaliera di Padova Identifier:
First received: July 23, 2012
Last updated: November 19, 2014
Last verified: November 2014
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.

Renal Hypoperfusion

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Hemodynamic Indexes and Renal Perfusion: Indirect Evaluation of Blood Volume Using the Association Between ScvO2 and Urinary Electrolytes in Patients Undergoing Major Surgery.

Resource links provided by NLM:

Further study details as provided by Dr. Paolo Feltracco, Azienda Ospedaliera di Padova:

Primary Outcome Measures:
  • 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) ]

Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing major surgery.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01650103

Contact: Andrea Bortolato, M.D. +393316169933
Contact: Paolo Feltracco, M.D. +393493410225

Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Contact    +390498218285      
Contact    +390498218286      
Principal Investigator: Andrea Bortolato, M.D.         
Sub-Investigator: Daniele Bonvicini, M.D.         
Sub-Investigator: Tommaso Tonetti, M.D.         
Principal Investigator: Paolo Feltracco, M.D.         
Sponsors and Collaborators
Azienda Ospedaliera di Padova
Study Chair: Carlo Ori, Prof. M.D. Università degli Studi di Padova
Principal Investigator: Paolo Feltracco, M.D. Azienda Ospedaliera di Padova
Principal Investigator: Andrea Bortolato, M.D. Azienda Ospedaliera di Padova
  More Information

Responsible Party: Dr. Paolo Feltracco, Principal Investigator, Azienda Ospedaliera di Padova Identifier: NCT01650103     History of Changes
Other Study ID Numbers: 2660P
Study First Received: July 23, 2012
Last Updated: November 19, 2014

Keywords provided by Dr. Paolo Feltracco, Azienda Ospedaliera di Padova:
renal hypoperfusion
major surgery
hemodynamic indexes

Additional relevant MeSH terms:
Pathologic Processes processed this record on May 25, 2017