NCT03037138

Brief Summary

Hemodialysis patients frequently complain of postdialysis fatigue and washed-out feeling. The aim of this study is to use blood flow rate (BFR) profiling to mitigate postdialysis washed-out state.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2016

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2016

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

23 days

First QC Date

January 24, 2017

Last Update Submit

January 27, 2017

Conditions

Hemodialysis-Induced Symptom

Keywords

postdialysis washed-out

Outcome Measures

Primary Outcomes (1)

  • Washed-out Scale

    Scale of washed-out degree after dialysis

    after 9 modified dialysis session (21 dyas from start of study)

Secondary Outcomes (1)

  • Urea reduction Rate

    after 9 modified dialysis session (21 dyas from start of study)

Study Arms (1)

Washed-out scale after using BFR profiling

OTHER

Blood flow profiling will be used as intervention for washed-out dialysis patients

Other: Blood flow Rate profiling

Interventions

Blood flow Rate profilingOTHER

Blood flow rate profiling during dialysis session

Washed-out scale after using BFR profiling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemodialysis Patient
  • Postdialysis washed-out complain

You may not qualify if:

  • schedule-non complaint patients
  • Patients with recent blood pressure drug modification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Use of blood flow profiling for prevention of postdialysis washed-out feeling through same group scale before and after profiling
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Nephrology in Internal Medicine Department

Study Record Dates

First Submitted

January 24, 2017

First Posted

January 31, 2017

Study Start

November 12, 2016

Primary Completion

December 5, 2016

Study Completion

January 1, 2017

Last Updated

January 31, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share