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

Hypovolemia Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01650103
• Other study ID #: 2660P
• Status: Recruiting
• Phase: N/A
• First received: July 23, 2012
• Last updated: November 19, 2014
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: November 2014
• Source: Azienda Ospedaliera di Padova
• Contact: Andrea Bortolato, M.D.
• Phone: +393316169933
• Email: freeandrea.b[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hypovolemia
• Renal Hypoperfusion

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera di Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of mixed oxygen saturation in central venous blood (ScvO2) and three urinary electrolytes (sodium, potassium, chloride)		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)	No