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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis-Induced Symptom
• Intervention / Treatment: Other: Blood flow Rate profiling

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hemodialysis Patient
• Postdialysis washed-out complain

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Washed-out Scale	Scale of washed-out degree after dialysis	after 9 modified dialysis session (21 dyas from start of study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urea reduction Rate	change in urea reduction rate after use of blood flow rate profiling	after 9 modified dialysis session (21 dyas from start of study)

Collaborators and Investigators

• Sponsor: Benha University
• Collaborators: New Jeddah Clinic Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 12, 2016
• Primary Completion (ACTUAL): December 5, 2016
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (ESTIMATE): January 31, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 27, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: postdialysis washed-out
• Other Study ID Numbers: BenhaU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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