NCT07360769

Brief Summary

The goal of this clinical trial is to detect if lower dialysate flow rate can affect hemodialysis adequacy , dialysis recovery time and patients quality of life. The main questions it aims to answer are: does low dialysate flow affect hemodialysis adequacy? does green dialysis achievable without affecting hemodialysis adequacy? Researchers will compare hemodialysis session of high dialysate flow to that with low dialysate flow. Participants will: underwent hemodialysis for a week with low dialysate flow and another week with high dialysate flow.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
Last Updated

January 22, 2026

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

December 15, 2025

Last Update Submit

January 17, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • The change of dialysate flow rate, for three successive conventional hemodialysis sessions, from 500ml/min to 300ml/min and its impact on hemodialysis adequacy that is assessed by urea reduction ratio (URR).

    Two weeks

  • The change of dialysate flow rate, for three successive conventional hemodialysis sessions, from 500ml/min to 300ml/min and its impact on hemodialysis adequacy that is assessed by and single-pool Kt/V (spKt/V) using the Daugirdas formula.

    Two weeks

Secondary Outcomes (2)

  • The effect of lowering dialysate flow rate from 500ml/min (milli per minute) to 300ml/min on dialysis recovery time (DRT) in minutes. Longer duration indicates lower dialysis adequacy.

    two weeks

  • The patients reported outcome measures that is assessed by palliative care Outcome Scale - Symptoms Renal (POS S renal). Each symptom takes a score from zero to four (0-4), high score indicates less efficient dialysis.

    Tow weeks

Study Arms (1)

ESKD patients

ACTIVE COMPARATOR
Other: lower dialysate flow rate ( 300ml/min). then testing its effect on hemodialysis adequacy

Interventions

The aim of this study is to check whether change of dialysate flow from 500ml/min to 300ml/min has a significant impact on dialysis adequacy , dialysis recovery time and patient reported outcome measures in maintenance hemodialysis patients.

ESKD patients

Eligibility Criteria

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

You may qualify if:

  • ESKD patients more than or equal 18 years old, on maintenance HD thrice weekly for more than three months and each session lasts for 4 hours.
  • All patients will receive HD via an arterio-venous fistula.
  • All patients will receive HD via the same type of HD machine and the blood pump will be set at 300ml/min.
  • All patients will receive the same type of HD membranes and every effort will be made to achieve the dry weight of the patients.

You may not qualify if:

  • Critically ill and hospitalized ESKD patients.
  • Mentally disabled patients.
  • Patients with terminal malignancy or receiving chemotherapy.
  • Patients receiving immune suppression treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Alexandria University

Alexandria, Egypt

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2025

First Posted

January 22, 2026

Study Start

June 1, 2025

Primary Completion

August 30, 2025

Study Completion

September 30, 2025

Last Updated

January 22, 2026

Record last verified: 2025-03

Locations