Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal on Hemodialysis

Completed

• Conditions: End Stage Renal Failure on Dialysis; Impedance; Cardiac Output, Low; Body Fluid Retention
• Interventions: Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis; Device: BCM- Body Composition Monitor, Fresenius Medical Care; Device: SCHILLER, BR-102 plus, Ambulatory Blood Pressure Monitoring System

• Registration Number: NCT02485782
• Lead Sponsor: Medical University of Warsaw

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-06-30
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-20
• Last Update Posted: 2015-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemodialysis patients	CardioScreen 1000 - Haemodynamic Measurement System, Medis	* 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
Hemodialysis patients	SCHILLER, BR-102 plus, Ambulatory Blood Pressure Monitoring System	* 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
Hemodialysis patients	BCM- Body Composition Monitor, Fresenius Medical Care	* 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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 volumetric hemodynamic parameter- stroke volume [ml] induced by fluid removal on hemodialysis.	1 day
Changes in blood pressure values [mmHg] induced by fluid removal on hemodialysis.	1 day

Trial Locations

Locations (1)

Medical University of Warsaw; 🇵🇱 Warsaw, Mazovian, Poland