Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal on Hemodialysis (CI/HD)

September 20, 2015 updated by: Łukasz Czyżewski, Medical University of Warsaw
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Mazovian
      • Warsaw, Mazovian, Poland, 02-091
        • Medical University of Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 80 consecutive patients on maintenance hemodialysis were included in this study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hemodialysis patients
  • midweek dialysis session
  • 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
Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis
Impedance cardiography (ICG)
Device: BCM- Body Composition Monitor, Fresenius Medical Care
Information about the individual fluid status and the nutritional status.
Device: SCHILLER, BR-102 plus, Ambulatory Blood Pressure Monitoring System
Blood pressure monitoring every 15 min during hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in volumetric hemodynamic parameter- cardiac index [l/min/m2]) induced by fluid removal on hemodialysis.
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in volumetric hemodynamic parameter- stroke volume [ml] induced by fluid removal on hemodialysis.
Time Frame: 1 day
1 day
Changes in volumetric hemodynamic parameter- systemic vascular resistance [dyn·s·cm-5] induced by fluid removal on hemodialysis.
Time Frame: 1 day
1 day
Changes in fluid removal parameter- thoracic fluid content [1/kOhm] during hemodialysis.
Time Frame: 1 day
1 day
Changes in blood pressure values [mmHg] induced by fluid removal on hemodialysis.
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Study Chair: Janusz Wyzgał, Professor, Medical University of Warsaw, Department of Nephrologic Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

September 20, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.I/HD/2015/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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