Evaluation of Hemodynamics and Amount of Blood Flowing Through the Kidneys by Measuring Some Physiological Substances in Blood and Urines
Verified November 2014 by Azienda Ospedaliera di Padova
Information provided by (Responsible Party):
Dr. Paolo Feltracco, Azienda Ospedaliera di Padova
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.
||Observational Model: Case-Only
Time Perspective: Cross-Sectional
||Hemodynamic Indexes and Renal Perfusion: Indirect Evaluation of Blood Volume Using the Association Between ScvO2 and Urinary Electrolytes in Patients Undergoing Major Surgery.
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2015 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients undergoing major surgery.
- thoracic-abdominal major surgical operations
- placing of a central venous catheter and urinary catheter
- age 18-75
- ASA class I-III
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01650103
|Azienda Ospedaliera di Padova
|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. |
Azienda Ospedaliera di Padova
||Carlo Ori, Prof. M.D.
||Università degli Studi di Padova
||Paolo Feltracco, M.D.
||Azienda Ospedaliera di Padova
||Andrea Bortolato, M.D.
||Azienda Ospedaliera di Padova
No publications provided
||Dr. Paolo Feltracco, Principal Investigator, Azienda Ospedaliera di Padova
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 23, 2012
||November 19, 2014
||Italy: Ethics Committee
Keywords provided by Azienda Ospedaliera di Padova:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 20, 2014