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Effect of Passive Leg Raising for Fluid Responsiveness

Primary Purpose

Body Fluid Retention, Impedance, Cardiac Output, Low

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
CardioScreen 1000 - Haemodynamic Measurement System, Medis
SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Fluid Retention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University of Warsaw, Department of Emergency Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

neutral position

legs raised for 20 degrees

legs raised for 30 degrees

legs raised for 45 degrees

legs raised for 60 degrees

Arm Description

the patient is in the neutral position, located on his back on a flat surface

patient is placed on a flat surface, legs raised for 20 degrees, supported around ankles

patient is placed on a flat surface, legs raised for 30 degrees, supported around ankles

patient is placed on a flat surface, legs raised for 45 degrees, supported around ankles

patient is placed on a flat surface, legs raised for 60 degrees, supported around ankles

Outcomes

Primary Outcome Measures

Changes in volumetric hemodynamic parameter- cardiac index [l/min/m2]) induced by fluid removal on leg elevation

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2016
Last Updated
March 8, 2016
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT02702544
Brief Title
Effect of Passive Leg Raising for Fluid Responsiveness
Official Title
Effect of Passive Leg Rasing on Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Fluid Retention, Impedance, Cardiac Output, Low

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
neutral position
Arm Type
Experimental
Arm Description
the patient is in the neutral position, located on his back on a flat surface
Arm Title
legs raised for 20 degrees
Arm Type
Experimental
Arm Description
patient is placed on a flat surface, legs raised for 20 degrees, supported around ankles
Arm Title
legs raised for 30 degrees
Arm Type
Experimental
Arm Description
patient is placed on a flat surface, legs raised for 30 degrees, supported around ankles
Arm Title
legs raised for 45 degrees
Arm Type
Experimental
Arm Description
patient is placed on a flat surface, legs raised for 45 degrees, supported around ankles
Arm Title
legs raised for 60 degrees
Arm Type
Experimental
Arm Description
patient is placed on a flat surface, legs raised for 60 degrees, supported around ankles
Intervention Type
Device
Intervention Name(s)
CardioScreen 1000 - Haemodynamic Measurement System, Medis
Intervention Description
Impedance cardiography (ICG)
Intervention Type
Device
Intervention Name(s)
SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System
Intervention Description
Blood pressure monitoring every 1 min during leg elevation
Primary Outcome Measure Information:
Title
Changes in volumetric hemodynamic parameter- cardiac index [l/min/m2]) induced by fluid removal on leg elevation
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Changes in volumetric hemodynamic parameter- stroke volume [ml] induced by fluid removal on leg elevation
Time Frame
1 day
Title
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
Title
Changes in fluid removal parameter- thoracic fluid content [1/kOhm] during leg elevation
Time Frame
1 day
Title
Changes in blood pressure values [mmHg] induced by fluid removal on leg elevation
Time Frame
1 day
Title
Changes in vascular parameter- thoracic arterial complicance [ml/mmHg/m-2] during leg elevation
Time Frame
1 day
Title
Changes in contractility parameter- acceleration index [1/100/s-2] during leg elevation
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak, PhD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Warsaw, Department of Emergency Medicine
City
Warsaw
State/Province
Masovia
ZIP/Postal Code
02-005
Country
Poland

12. IPD Sharing Statement

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Effect of Passive Leg Raising for Fluid Responsiveness

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