NCT02702544

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

Same day

First QC Date

March 3, 2016

Last Update Submit

March 8, 2016

Conditions

Body Fluid RetentionImpedanceCardiac Output, Low

Outcome Measures

Primary Outcomes (1)

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

    1 day

Secondary Outcomes (6)

  • Changes in volumetric hemodynamic parameter- stroke volume [ml] induced by fluid removal on leg elevation

    1 day

  • Changes in volumetric hemodynamic parameter- systemic vascular resistance index [dyn·s·cm-5·m-2] induced by fluid removal on leg elevation

    1 day

  • Changes in fluid removal parameter- thoracic fluid content [1/kOhm] during leg elevation

    1 day

  • Changes in blood pressure values [mmHg] induced by fluid removal on leg elevation

    1 day

  • Changes in vascular parameter- thoracic arterial complicance [ml/mmHg/m-2] during leg elevation

    1 day

  • +1 more secondary outcomes

Study Arms (5)

neutral position

EXPERIMENTAL

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

Device: CardioScreen 1000 - Haemodynamic Measurement System, MedisDevice: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System

legs raised for 20 degrees

EXPERIMENTAL

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

Device: CardioScreen 1000 - Haemodynamic Measurement System, MedisDevice: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System

legs raised for 30 degrees

EXPERIMENTAL

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

Device: CardioScreen 1000 - Haemodynamic Measurement System, MedisDevice: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System

legs raised for 45 degrees

EXPERIMENTAL

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

Device: CardioScreen 1000 - Haemodynamic Measurement System, MedisDevice: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System

legs raised for 60 degrees

EXPERIMENTAL

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

Device: CardioScreen 1000 - Haemodynamic Measurement System, MedisDevice: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System

Interventions

CardioScreen 1000 - Haemodynamic Measurement System, MedisDEVICE

Impedance cardiography (ICG)

legs raised for 20 degreeslegs raised for 30 degreeslegs raised for 45 degreeslegs raised for 60 degreesneutral position
SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring SystemDEVICE

Blood pressure monitoring every 1 min during leg elevation

legs raised for 20 degreeslegs raised for 30 degreeslegs raised for 45 degreeslegs raised for 60 degreesneutral position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw, Department of Emergency Medicine

Warsaw, Masovia, 02-005, Poland

Location

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lukasz Szarpak, PhD

    Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 8, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 9, 2016

Record last verified: 2016-03

Locations

PL(1)