Evaluation of Hemodynamics and Amount of Blood Flowing Th... | NCT01650103

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

NCT01650103

Sponsor

Azienda Ospedaliera di Padova

Status

Unknown status

Last Update Posted

Nov 20, 2014Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Hypovolemia
Renal Hypoperfusion

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jul 23, 2012

First Submission Date that Met QC Criteria

Jul 25, 2012

First Posted Date

Jul 26, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2014

Last Update Posted Date

Nov 20, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Paolo Feltracco, Principal Investigator, Azienda Ospedaliera di PadovaPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera di PadovaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing major surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrea Bortolato, M.D.	Contact	+393316169933		freeandrea.b@libero.it
Paolo Feltracco, M.D.	Contact	+393493410225		paolofeltracco@inwind.it

Overall Officials

Name	Affiliation	Role
Carlo Ori, Prof. M.D.	University of Padova	Study Chair
Paolo Feltracco, M.D.	Azienda Ospedaliera di Padova	Principal Investigator
Andrea Bortolato, M.D.

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliera di Padova	Recruiting	Padova	Padova	35128	Italy

Condition Browse Module

MeSH Terms

ID	Term
D020896	Hypovolemia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided