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Completed

NCT Number: NCT02485782

Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal on Hemodialysis

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) beginning 15 min prior to midweek dialysis session and continuous measurement thereafter, with a 15-min period after the termination of hemodialysis. Fluid overload were measured by BCM Monitor Fresenius before hemodialysis.

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Key information

Conditions

End Stage Renal Failure on Dialysis Body Fluid Retention Cardiac Output, Low Cardiovascular Diseases Heart Diseases Impedance Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Warsaw

Warsaw, Mazovian, 02-091, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • give voluntary consent to participate in the study
  • patients on maintenance hemodialysis at least 3 months
  • stable dry weight
  • single-pool Kt/V >1.4
  • no clinical cardiovascular disease during the 6 months preceding entry

Exclusion criteria

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

Treatment and study plan

CardioScreen 1000 - Haemodynamic Measurement System, Medis

Device

Impedance cardiography (ICG)

BCM- Body Composition Monitor, Fresenius Medical Care

Device

Information about the individual fluid status and the nutritional status.

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

Device

Blood pressure monitoring every 15 min during hemodialysis

Primary outcomes

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

    Time frame: 1 day

Secondary outcomes

  1. Changes in volumetric hemodynamic parameter- stroke volume [ml] induced by fluid removal on hemodialysis.

    Time frame: 1 day

  2. Changes in volumetric hemodynamic parameter- systemic vascular resistance [dyn·s·cm-5] induced by fluid removal on hemodialysis.

    Time frame: 1 day

  3. Changes in fluid removal parameter- thoracic fluid content [1/kOhm] during hemodialysis.

    Time frame: 1 day

  4. Changes in blood pressure values [mmHg] induced by fluid removal on hemodialysis.

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Acronym: CI/HD

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 30, 2015
Registry last updated
Sep 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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