Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal on Hemodialysis

End Stage Renal Failure on Dialysis Clinical Trial

— CI/HD  

Official title:

Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485782
• Other study ID #: C.I/HD/2015/06
• Status: Completed
• Phase: N/A
• First received: June 26, 2015
• Last updated: September 20, 2015
• Start date: June 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Body Fluid Retention
• Cardiac Output, Low
• End Stage Renal Failure on Dialysis
• Impedance
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warsaw	Mazovian

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in volumetric hemodynamic parameter- cardiac index [l/min/m2]) induced by fluid removal on hemodialysis.		1 day	No
Secondary	Changes in volumetric hemodynamic parameter- stroke volume [ml] induced by fluid removal on hemodialysis.		1 day	No
Secondary	Changes in volumetric hemodynamic parameter- systemic vascular resistance [dyn·s·cm-5] induced by fluid removal on hemodialysis.		1 day	No
Secondary	Changes in fluid removal parameter- thoracic fluid content [1/kOhm] during hemodialysis.		1 day	No
Secondary	Changes in blood pressure values [mmHg] induced by fluid removal on hemodialysis.		1 day	No