Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal on Hemodialysis

NCT ID: NCT02485782

Last Updated: 2015-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

CardioScreen 1000 - Haemodynamic Measurement System, Medis

Intervention Type DEVICE

Impedance cardiography (ICG)

BCM- Body Composition Monitor, Fresenius Medical Care

Intervention Type DEVICE

Information about the individual fluid status and the nutritional status.

SCHILLER, BR-102 plus, Ambulatory Blood Pressure Monitoring System

Intervention Type DEVICE

Blood pressure monitoring every 15 min during hemodialysis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CardioScreen 1000 - Haemodynamic Measurement System, Medis

Impedance cardiography (ICG)

Intervention Type DEVICE

BCM- Body Composition Monitor, Fresenius Medical Care

Information about the individual fluid status and the nutritional status.

Intervention Type DEVICE

SCHILLER, BR-102 plus, Ambulatory Blood Pressure Monitoring System

Blood pressure monitoring every 15 min during hemodialysis

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Łukasz Czyżewski

Łukasz Czyżewski

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Janusz Wyzgał, Professor

Role: STUDY_CHAIR

Medical University of Warsaw, Department of Nephrologic Nursing

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of Warsaw

Warsaw, Mazovian, Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25365639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24770703 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25382249 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C.I/HD/2015/06

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dehydr8 and Deactiv8
NCT03179072 COMPLETED