NCT03499860

Brief Summary

The aim of the study is to evaluate whether changes in Perfusion Index (PI) and Pleth Variability Index (PVI) during passive leg raising test can predict fluid responsiveness in spontaneously breathing patients. Fluid responsive patients are defined as showing an increase in cardiac output \>10% during a passive leg raising test, measured semi-invaseively with FloTrac® (Edwards LifeSciences. Irvine, United States).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

April 20, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

12 months

First QC Date

March 31, 2018

Last Update Submit

July 18, 2019

Conditions

Fluid Responsiveness

Outcome Measures

Primary Outcomes (2)

  • PI difference

    Difference in the change of perfusion index from baseline during a passive leg raising maneuver in fluid responsive patients compared to fluid non-responders

    90 seconds

  • PVI difference

    Difference in the change of pleth variability index from baseline during a passive leg raising maneuver in fluid responsive patients compared to fluid non-responders

    90 seconds

Interventions

Passive Leg Raising TestDIAGNOSTIC_TEST

A passive leg raising test is performed in all patients included in the study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients admitted to the intensive or intermediate care unit after abdominal surgery (including urological and gynecological surgery performed in laparotomy)
  • Spontaneous breathing
  • Arterial line already in place
  • Oral and written informed consent obtained

You may not qualify if:

  • Age \<18 years
  • Abdominal trauma as the reason for surgery
  • Missing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"F. Tappeiner" Hospital Merano

Merano, Bolzano, 39012, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

March 31, 2018

First Posted

April 17, 2018

Study Start

April 20, 2018

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

July 22, 2019

Record last verified: 2019-07

Locations

IT(1)