- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07360769
Optimizing Hemodialysis: How Low Dialysate Flow Alters Adequacy and Patient Recovery.
Low Dialysate Flow: Its Effect on Hemodialysis Adequacy, Dialysis Recovery Time and Patient Reported Outcome Measures.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Alexandria, Egypt
- Faculty of Medicine Alexandria University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria :
- Critically ill and hospitalized ESKD patients.
- Mentally disabled patients.
- Patients with terminal malignancy or receiving chemotherapy.
- Patients receiving immune suppression treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: ESKD patients
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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).
Time Frame: Two weeks
|
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.
Time Frame: Two weeks
|
Two weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
Time Frame: two weeks
|
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.
Time Frame: Tow weeks
|
Tow weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Pathological Conditions, Signs and Symptoms
- Kidney Failure, Chronic
Other Study ID Numbers
- 0108861
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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