Other Clinical Trial - Randomised Study of High-flux Haemodialysis &

Status Completed

Clinical Trial Summary

The most common forms of renal replacement therapy currently in use are high flux haemodialysis (HF-HD) and haemodiafiltration (HDF). Although these techniques appear similar to the patient, there are important differences in what happens to the blood as it travels through the dialysis machine.

During HDF, the machine controls hydrostatic pressure across the dialyser to remove additional water together with toxins from the blood and this fluid volume is continually replaced with an ultra-pure solution. HDF has a theoretical advantage removing more waste substances, especially larger molecules, from the blood than HF-HD which may be of benefit to the patient in the medium to long term.Despite the theoretical advantages, trials have so far been unable to find any significant difference in death rates or the development of health problems among patients on HDF or HF-HD.

It is therefore important to examine other factors which may help doctors and patients to decide which treatment to use. The investigators have designed a study which aims to answer three main questions:

1. Does HDF make patients feel better?

2. Is blood pressure more stable on HDF in comparison with HF-HD?

3. Are Phosphate levels and other blood parameters better controlled with HDF than HF-HD?

The investigators will do this by randomly assigning patients on HF-HD to receive 2 months of either HF-HD or HDF with as equivalent treatment prescriptions as possible and without the patient knowing which treatment they are receiving. After two months the patients will switch to the alternative form of dialysis for a further two months. During the study the investigators will ask the patients how long it took them to recover from the preceding session of dialysis, assess the frequency of symptomatic low blood pressure and also perform blood tests at set intervals to measure specific blood parameters.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01862679
Study type	Interventional
Source	NHS Greater Glasgow and Clyde
Contact
Status	Completed
Phase	N/A
Start date	July 2013
Completion date	March 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04076488` - Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases	N/A
Completed	`NCT03289650` - Extended Release Tacrolimus vs. Twice-Daily Tacrolimus	Phase 3
Completed	`NCT04042324` - A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients	Phase 1/Phase 2
Completed	`NCT01242904` - Use of a Bimodal Solution for Peritoneal Dialysis	Phase 2
Active, not recruiting	`NCT03183245` - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis	Phase 3
Completed	`NCT03257410` - Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients	N/A
Completed	`NCT03627299` - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors	Phase 4
Recruiting	`NCT05917795` - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates	N/A
Terminated	`NCT03539861` - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients	N/A
Withdrawn	`NCT02130817` - Belatacept in Kidney Transplantation of Moderately Sensitized Patients	Phase 4
Completed	`NCT05540457` - Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)	N/A
Not yet recruiting	`NCT04900610` - The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis	N/A
Recruiting	`NCT02176434` - Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease	N/A
Active, not recruiting	`NCT02581449` - Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis	Phase 2
Completed	`NCT02134314` - C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI	Phase 1/Phase 2
Completed	`NCT02830490` - Reliability of Functional Measures in Hemodialysis Patient.	N/A
Completed	`NCT02832466` - Quantifying the Deterioration of Physical Function in Renal Patients	N/A
Completed	`NCT02832440` - Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis	N/A
Completed	`NCT02215655` - Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence	N/A
Recruiting	`NCT01912001` - Virtual Ward for Home Dialysis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Randomised Study of High-flux Haemodialysis and Haemodiafiltration

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms