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Use Of Blood Flow Rate Profiling For Postdialysis Washed-Out Patients

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ClinicalTrials.gov Identifier: NCT03037138
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Collaborator:
New Jeddah Clinic Hospital
Information provided by (Responsible Party):
Mahmoud Hamada imam, Benha University

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.

Condition or disease Intervention/treatment Phase
Hemodialysis-Induced Symptom Other: Blood flow Rate profiling Not Applicable

Detailed Description:
Hemodialysis patients who complain of the postdialysis washed-out state were recruited. blood flow rate was altered to be 350 ml/min in the first hour of the session then decreased by 50 ml/min hourly for the 4-hour dialysis session. blood flow rate profiling was continued for 9 dialysis sessions (21 Days). Patients were asked to grade their washed-out state on a scale from 1 (no washed-out state) to 5 (severe washed-out state) before and after blood flow rate profiling. Paired t=-test and Wilcoxon Signed Ranks Test were used in appropriate context to compare washed out scale before and after together with urea reduction rate and other blood chemistry tests.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Use of blood flow profiling for prevention of postdialysis washed-out feeling through same group scale before and after profiling
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use Of Blood Flow Rate Profiling For Postdialysis Washed-Out Patients
Actual Study Start Date : November 12, 2016
Actual Primary Completion Date : December 5, 2016
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Washed-out scale after using BFR profiling
Blood flow profiling will be used as intervention for washed-out dialysis patients
Other: Blood flow Rate profiling
Blood flow rate profiling during dialysis session




Primary Outcome Measures :
  1. Washed-out Scale [ Time Frame: after 9 modified dialysis session (21 dyas from start of study) ]
    Scale of washed-out degree after dialysis


Secondary Outcome Measures :
  1. Urea reduction Rate [ Time Frame: after 9 modified dialysis session (21 dyas from start of study) ]
    change in urea reduction rate after use of blood flow rate profiling



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemodialysis Patient
  • Postdialysis washed-out complain

Exclusion Criteria:

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

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Responsible Party: Mahmoud Hamada imam, Lecturer of Nephrology in Internal Medicine Department, Benha University
ClinicalTrials.gov Identifier: NCT03037138     History of Changes
Other Study ID Numbers: BenhaU
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mahmoud Hamada imam, Benha University:
postdialysis washed-out