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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02702544
Other study ID # 02.014.1MR
Secondary ID
Status Enrolling by invitation
Phase N/A
First received March 3, 2016
Last updated March 8, 2016
Start date March 2016
Est. completion date March 2016

Study information

Verified date March 2016
Source Medical University of Warsaw
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Science and Higher Education
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 80
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
CardioScreen 1000 - Haemodynamic Measurement System, Medis
Impedance cardiography (ICG)
SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System
Blood pressure monitoring every 1 min during leg elevation

Locations

Country Name City State
Poland Medical University of Warsaw, Department of Emergency Medicine Warsaw Masovia

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in volumetric hemodynamic parameter- cardiac index [l/min/m2]) induced by fluid removal on leg elevation 1 day No
Secondary Changes in volumetric hemodynamic parameter- stroke volume [ml] induced by fluid removal on leg elevation 1 day No
Secondary Changes in volumetric hemodynamic parameter- systemic vascular resistance index [dyn·s·cm-5·m-2] induced by fluid removal on leg elevation 1 day No
Secondary Changes in fluid removal parameter- thoracic fluid content [1/kOhm] during leg elevation 1 day No
Secondary Changes in blood pressure values [mmHg] induced by fluid removal on leg elevation 1 day No
Secondary Changes in vascular parameter- thoracic arterial complicance [ml/mmHg/m-2] during leg elevation 1 day No
Secondary Changes in contractility parameter- acceleration index [1/100/s-2] during leg elevation 1 day No
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