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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Azienda Ospedaliera di Padova
Sponsor:
Information provided by (Responsible Party):
Dr. Paolo Feltracco, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier:
NCT01650103
First received: July 23, 2012
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

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.


Condition
Hypovolemia
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 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) ] [ Designated as safety issue: No ]

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)
  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 major surgery.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650103

Contacts
Contact: Andrea Bortolato, M.D. +393316169933 freeandrea.b@libero.it
Contact: Paolo Feltracco, M.D. +393493410225 paolofeltracco@inwind.it

Locations
Italy
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
Investigators
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

No publications provided

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

Keywords provided by Azienda Ospedaliera di Padova:
hypovolemia
renal hypoperfusion
major surgery
sodium
potassium
chloride
ScvO2
hemodynamic indexes

Additional relevant MeSH terms:
Hypovolemia
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014