NCT02443376

Brief Summary

Central blood pressure and pulse wave velocity were measured using a Complior Analyse device before and immediately after the end of the dialysis session.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 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

May 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 2, 2015

Status Verified

September 1, 2015

Enrollment Period

2 months

First QC Date

May 10, 2015

Last Update Submit

September 30, 2015

Conditions

Arteriopathic DiseaseArterial CalcificationComplication of HemodialysisAortic Stiffness

Outcome Measures

Primary Outcomes (1)

  • Differences in carotid-femoral pulse wave velocity [m/s] just before and after hemodialysis session

    1 day

Secondary Outcomes (3)

  • Differences in central aortic pressure [mmHg] just before and after hemodialysis session

    1 day

  • Differences in central aortic pressure [mmHg] and cuff blood pressure [mmHg] just before and after hemodialysis session

    1 day

  • Impact of fluid and nutritional status on carotid-femoral pulse wave velocity and central aortic pressure

    1 day

Study Arms (2)

Hemodialysis patients

Stable end-stage renal disease patients on maintenance conventional hemodialysis received 4-5 hours of treatment thrice weekly. Pulse wave velocity and central aortic pressure was measured before and after the midweek dialysis session.Overhydration Urea distribution volume (V) Total body water, extracellular and intracellular water Lean Tissue Index (LTI) Fat Tissue Index (FTI) Body Cell Mass (BCM) was measured before the midweek dialysis session just after Complior device

Device: Complior Analyse SystemDevice: BCM- Body Composition Monitor

Healthy subjects

Medical staff: medical doctors, nurses

Device: Complior Analyse System

Interventions

Complior Analyse SystemDEVICE

Pulse Wave Velocity PWV and central Pressure analysis

Healthy subjectsHemodialysis patients
BCM- Body Composition MonitorDEVICE

BCM - Body Composition Monitor gives information about: Overhydration Urea distribution volume (V) Total body water, extracellular and intracellular water Lean Tissue Index (LTI) Fat Tissue Index (FTI) Body Cell Mass (BCM)

Hemodialysis patients

Eligibility Criteria

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

A total of 80 consecutive patients on maintenance hemodialysis and 30 healthy subjects 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
  • medical staff (medical doctors, nurses)

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. 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

  • 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: 25365639RESULT

  • 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: 24770703RESULT

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
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lukasz Czyzewski

Study Record Dates

First Submitted

May 10, 2015

First Posted

May 13, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

October 2, 2015

Record last verified: 2015-09

Locations

PL(1)