Clinical trial NCT02485782: Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal on Hemodialysis
Official title: Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal on Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Failure on Dialysis
Body Fluid Retention
Impedance
Cardiac Output, Low
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 80 consecutive patients on maintenance hemodialysis were included in this study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in volumetric hemodynamic parameter- cardiac index [l/min/m2]) induced by fluid removal on hemodialysis.
timeFrame: 1 day
Secondary outcomes:
measure: Changes in volumetric hemodynamic parameter- stroke volume [ml] induced by fluid removal on hemodialysis.
timeFrame: 1 day
measure: Changes in volumetric hemodynamic parameter- systemic vascular resistance [dyn·s·cm-5] induced by fluid removal on hemodialysis.
timeFrame: 1 day
measure: Changes in fluid removal parameter- thoracic fluid content [1/kOhm] during hemodialysis.
timeFrame: 1 day
measure: Changes in blood pressure values [mmHg] induced by fluid removal on hemodialysis.
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
state: Mazovian
Study officials:
affiliation: Medical University of Warsaw, Department of Nephrologic Nursing
name: Janusz Wyzgał, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.