NCT03727503

Brief Summary

The goal of this study is to assess the ability of a new smartphone PPV app to predict fluid responsiveness in cardiac surgical patients in the Intensive care unit (in the postoperative period)

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

October 29, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 27, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

October 29, 2018

Last Update Submit

January 27, 2020

Conditions

Surgery

Outcome Measures

Primary Outcomes (2)

  • PPV measure

    PPV before with after 2 maneuvers which modify PPV (increase PEEP level and mini-fluid challenge)

    baseline

  • PPV measure

    PPV before with after 2 maneuvers which modify PPV (increase PEEP level and mini-fluid challenge)

    1 minute after the end of volume expansion

Study Arms (1)

group/cohort

OTHER

operated patients from cardiac surgery. Once they arrived in the ICU, we will measure PPV with the capstesia and the PICCO device at baseline, and after a volume expansion of 500 ml of crystalloid.

Other: PPV from the capstesia

Interventions

PPV from the capstesiaOTHER

we will challenge the application by doing 2 maneuvers: the first one is to increase the PEEP level from 5 to 15 cmH2O and the second one is the infusion of a mini-fluid challenge (100 ml) followed by the other 400 ml.

group/cohort

Eligibility Criteria

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

You may qualify if:

  • adults patients ( \>18 years)
  • Patients scheduled for cardiac surgery
  • equipped with a femoral arterial catheter and the PICCO device

You may not qualify if:

  • Atrial fibrillation
  • severe cardiac dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

Location

Study Officials

  • Alexandre Joosten, M.D

    ERASME

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Agreement and precision between two methods to measure pulse pressure variation (PPV)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 29, 2018

First Posted

November 1, 2018

Study Start

March 27, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

January 29, 2020

Record last verified: 2020-01

Locations

BE(1)