NCT02485782

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) 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

3 months

First QC Date

June 26, 2015

Last Update Submit

September 20, 2015

Conditions

End Stage Renal Failure on DialysisBody Fluid RetentionImpedanceCardiac Output, Low

Outcome Measures

Primary Outcomes (1)

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

    1 day

Secondary Outcomes (4)

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

    1 day

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

    1 day

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

    1 day

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

    1 day

Study Arms (1)

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, MedisDevice: BCM- Body Composition Monitor, Fresenius Medical CareDevice: SCHILLER, BR-102 plus, Ambulatory Blood Pressure Monitoring System

Interventions

CardioScreen 1000 - Haemodynamic Measurement System, MedisDEVICE

Impedance cardiography (ICG)

Hemodialysis patients
BCM- Body Composition Monitor, Fresenius Medical CareDEVICE

Information about the individual fluid status and the nutritional status.

Hemodialysis patients
SCHILLER, BR-102 plus, Ambulatory Blood Pressure Monitoring SystemDEVICE

Blood pressure monitoring every 15 min during hemodialysis

Hemodialysis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • not meet the 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

Warsaw, Mazovian, 02-091, Poland

Location

Related Publications (3)

  • Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Comparative analysis of hypertension and its causes among renal replacement therapy patients. Ann Transplant. 2014 Nov 3;19:556-68. doi: 10.12659/AOT.891248.

    PMID: 25365639BACKGROUND

  • Czyzewski L, Wyzgal J, Kolek A. Evaluation of selected risk factors of cardiovascular diseases among patients after kidney transplantation, with particular focus on the role of 24-hour automatic blood pressure measurement in the diagnosis of hypertension: an introductory report. Ann Transplant. 2014 Apr 28;19:188-98. doi: 10.12659/AOT.890189.

    PMID: 24770703BACKGROUND

  • Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Assessment of health-related quality of life of patients after kidney transplantation in comparison with hemodialysis and peritoneal dialysis. Ann Transplant. 2014 Nov 9;19:576-85. doi: 10.12659/AOT.891265.

    PMID: 25382249BACKGROUND

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Janusz Wyzgał, Professor

    Medical University of Warsaw, Department of Nephrologic Nursing

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Łukasz Czyżewski

Study Record Dates

First Submitted

June 26, 2015

First Posted

June 30, 2015

Study Start

June 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

PL(1)