NCT02041403

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

January 18, 2014

Last Update Submit

January 21, 2014

Conditions

Major High Risk OperationsRenal Resistive IndexOutcome

Outcome Measures

Primary Outcomes (1)

  • Complications

    Recording any postoperative complication occurred within the first postoperative week

    7 post-operative days

Study Arms (1)

Renal resistive Index

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients submitted to major high risk surgery

You may qualify if:

  • age \> 18 years
  • major surgical operations

You may not qualify if:

  • age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sant'Ambrogio Clinical Institute - Cardiac Anesthesia Unit

Milan, Milano, 20100, Italy

Location

Humanitas Research Hospital - Dept. Anesthesia and Intensive Care Unit

Rozzano, Milano, 20089, Italy

Location

Study Officials

  • Enrico Giustiniano, MD

    Humanitas Research Hospital -Dept. Anesthesia and Intensive Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2014

First Posted

January 22, 2014

Study Start

June 1, 2012

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

January 23, 2014

Record last verified: 2014-01

Locations

IT(2)