Passive Leg Raising and Fluid Responsiveness

February 5, 2020 updated by: Matty Koopmans, Medical Centre Leeuwarden

Passive Leg Raising 3.0 and Fluid Responsiveness

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PLR test with pillow PLR test with bed to avoid a difference in results by the order of the measurements, the order of PLR testing is random.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leeuwarden, Netherlands, 8934AD
        • Medical Center Leeuwarden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted to the ICU with clinical signs of fluid need

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • age < 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fluid responsiveness expressed in volume
Time Frame: 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
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
Time Frame: test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days
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
Time Frame: test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Centre Leeuwarden

Investigators

  • Principal Investigator: Matty Koopmans, MSc, MCL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

June 9, 2017

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 7, 2020

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • nWMO 217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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