Effect of Passive Leg Raising for Fluid Responsiveness

March 8, 2016 updated by: Łukasz Szarpak, Medical University of Warsaw

Effect of Passive Leg Rasing on Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal

Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume, Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. GmbH Ilmenau) while lifting the leg at different angles. The measurement lasted 12 minutes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

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

  • Poland
    • Masovia
      • Warsaw, Masovia, Poland, 02-005
        • Medical University of Warsaw, Department of Emergency Medicine

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • give voluntary consent to participate in the study
  • no clinical cardiovascular disease during the 6 months proceeding entry

Exclusion Criteria:

  • not meet above criteria
  • episode of illness (for example: infection)
  • pregnancy

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: neutral position
the patient is in the neutral position, located on his back on a flat surface
Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis
Impedance cardiography (ICG)
Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System
Blood pressure monitoring every 1 min during leg elevation
EXPERIMENTAL: legs raised for 20 degrees
patient is placed on a flat surface, legs raised for 20 degrees, supported around ankles
Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis
Impedance cardiography (ICG)
Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System
Blood pressure monitoring every 1 min during leg elevation
EXPERIMENTAL: legs raised for 30 degrees
patient is placed on a flat surface, legs raised for 30 degrees, supported around ankles
Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis
Impedance cardiography (ICG)
Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System
Blood pressure monitoring every 1 min during leg elevation
EXPERIMENTAL: legs raised for 45 degrees
patient is placed on a flat surface, legs raised for 45 degrees, supported around ankles
Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis
Impedance cardiography (ICG)
Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System
Blood pressure monitoring every 1 min during leg elevation
EXPERIMENTAL: legs raised for 60 degrees
patient is placed on a flat surface, legs raised for 60 degrees, supported around ankles
Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis
Impedance cardiography (ICG)
Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System
Blood pressure monitoring every 1 min during leg elevation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in volumetric hemodynamic parameter- cardiac index [l/min/m2]) induced by fluid removal on leg elevation
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in volumetric hemodynamic parameter- stroke volume [ml] induced by fluid removal on leg elevation
Time Frame: 1 day
1 day
Changes in volumetric hemodynamic parameter- systemic vascular resistance index [dyn·s·cm-5·m-2] induced by fluid removal on leg elevation
Time Frame: 1 day
1 day
Changes in fluid removal parameter- thoracic fluid content [1/kOhm] during leg elevation
Time Frame: 1 day
1 day
Changes in blood pressure values [mmHg] induced by fluid removal on leg elevation
Time Frame: 1 day
1 day
Changes in vascular parameter- thoracic arterial complicance [ml/mmHg/m-2] during leg elevation
Time Frame: 1 day
1 day
Changes in contractility parameter- acceleration index [1/100/s-2] during leg elevation
Time Frame: 1 day
1 day

Collaborators and Investigators

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

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: Lukasz Szarpak, PhD, Medical University of Warsaw

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

March 1, 2016

Primary Completion (ANTICIPATED)

March 1, 2016

Study Completion (ANTICIPATED)

March 1, 2016

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (ESTIMATE)

March 8, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02.014.1MR

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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