Effect of Passive Leg Raising for Fluid Responsiveness

NCT ID: NCT02702544

Last Updated: 2016-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Body Fluid Retention Impedance Cardiac Output, Low

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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neutral position

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

Group Type EXPERIMENTAL

CardioScreen 1000 - Haemodynamic Measurement System, Medis

Intervention Type DEVICE

Impedance cardiography (ICG)

SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System

Intervention Type DEVICE

Blood pressure monitoring every 1 min during leg elevation

legs raised for 20 degrees

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

Group Type EXPERIMENTAL

CardioScreen 1000 - Haemodynamic Measurement System, Medis

Intervention Type DEVICE

Impedance cardiography (ICG)

SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System

Intervention Type DEVICE

Blood pressure monitoring every 1 min during leg elevation

legs raised for 30 degrees

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

Group Type EXPERIMENTAL

CardioScreen 1000 - Haemodynamic Measurement System, Medis

Intervention Type DEVICE

Impedance cardiography (ICG)

SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System

Intervention Type DEVICE

Blood pressure monitoring every 1 min during leg elevation

legs raised for 45 degrees

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

Group Type EXPERIMENTAL

CardioScreen 1000 - Haemodynamic Measurement System, Medis

Intervention Type DEVICE

Impedance cardiography (ICG)

SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System

Intervention Type DEVICE

Blood pressure monitoring every 1 min during leg elevation

legs raised for 60 degrees

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

Group Type EXPERIMENTAL

CardioScreen 1000 - Haemodynamic Measurement System, Medis

Intervention Type DEVICE

Impedance cardiography (ICG)

SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System

Intervention Type DEVICE

Blood pressure monitoring every 1 min during leg elevation

Interventions

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CardioScreen 1000 - Haemodynamic Measurement System, Medis

Impedance cardiography (ICG)

Intervention Type DEVICE

SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System

Blood pressure monitoring every 1 min during leg elevation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Łukasz Szarpak

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lukasz Szarpak, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

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Medical University of Warsaw, Department of Emergency Medicine

Warsaw, Masovia, Poland

Site Status

Countries

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Poland

Other Identifiers

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02.014.1MR

Identifier Type: -

Identifier Source: org_study_id

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