NCT04260841

Brief Summary

In the Intensive Care the Passive Leg Raising (PLR) test is a validated instrument to predict fluid responsiveness. In this study the investigators will try to prove the similarity of PLR test with a pillow and the PLR test with the patients bed in 45 degrees.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

2.4 years

First QC Date

June 9, 2017

Last Update Submit

February 5, 2020

Conditions

Passive Leg Raising

Keywords

fluid responsiveness

Outcome Measures

Primary Outcomes (3)

  • fluid responsiveness expressed in volume

    are both PLR tests similar / comparable on fluid responsiveness

    from ICU admission until ICU discharge; test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days

  • blood pressure expressed in mmHg

    are both PLR tests similar / comparable on fluid responsiveness

    test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days

  • cardiac output

    are both PLR tests similar / comparable on fluid responsiveness

    test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days

Interventions

bed in 45 degrees for passive leg raising testDEVICE

fluid responsiveness is tested by the passive leg raising test

Also known as: use of "pillow" for passive leg raising test

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the ICU with clinical signs of fluid need

You may qualify if:

  • admission on Intensive Care
  • clinical signs as; mean arterial pressure \< 60, lactate \> 2.0 mmol/L

You may not qualify if:

  • age \< 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center Leeuwarden

Leeuwarden, 8934AD, Netherlands

Location

MeSH Terms

Interventions

Beds

Intervention Hierarchy (Ancestors)

Equipment and Supplies, HospitalEquipment and Supplies

Study Officials

  • Matty Koopmans, MSc

    MCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research coordinator

Study Record Dates

First Submitted

June 9, 2017

First Posted

February 7, 2020

Study Start

June 1, 2017

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

February 7, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)