RENAL RESISTIVE INDEX POST-OPERATIVE COMPLICATIONS IN MAJ... | NCT02041403

Studies
RENAL RESISTIVE INDEX POST-OPERATIVE COMPLICATIONS IN MAJOR SURGERY?

NCT02041403

Sponsor

Istituto Clinico Humanitas

Status

Completed

Last Update Posted

Jan 23, 2014Estimated

Enrollment

218Actual

Phase

Not provided

Conditions

Major High Risk Operations
Renal Resistive Index
Outcome

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

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jun 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jan 18, 2014

First Submission Date that Met QC Criteria

Jan 18, 2014

First Posted Date

Jan 22, 2014Estimated

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

Jan 21, 2014

Last Update Posted Date

Jan 23, 2014Estimated

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

An observational trial aiming to verify whether does any relationship exist between renal resistive index and postoperative outcome in major high risk surgery

Detailed Description

Renal resistive index was measured just after major high risk operations and then patients were observed searching for any surgical and medical-related complications during the first post-operative week

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

218Actual

Label	Type	Description	Intervention Names
Renal resistive Index

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complications	Recording any postoperative complication occurred within the first postoperative week	7 post-operative days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18 years
major surgical operations

Exclusion Criteria:

age < 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients submitted to major high risk surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Enrico Giustiniano, MD	Humanitas Research Hospital -Dept. Anesthesia and Intensive Care	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sant'Ambrogio Clinical Institute - Cardiac Anesthesia Unit		Milan	Milano	20100	Italy
Humanitas Research Hospital - Dept. Anesthesia and Intensive Care Unit