## Protocol Section
### Identification Module
**NCT ID:** NCT01862679

**Brief Title:** Randomised Study of High-flux Haemodialysis and Haemodiafiltration

**Official Title:** Single Blind, Prospective, Randomised Comparative Study of High-flux Haemodialysis and Haemodiafiltration

#### Organization Study ID Info
**ID:** GN12RE153
#### Organization
**Class:** OTHER
**Full Name:** NHS Greater Glasgow and Clyde
### Status Module
#### Completion Date
**Date:** 2014-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-06-07

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-06-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-03

**Type:** ACTUAL

#### Start Date
**Date:** 2013-07

**Status Verified Date:** 2016-06

#### Study First Post Date
**Date:** 2013-05-24
**Type:** ESTIMATED
**Study First Submit Date:** 2013-04-22
**Study First Submit QC Date:** 2013-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** NHS Greater Glasgow and Clyde

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- End Stage Renal Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 8 weeks high-flux haemodialysis followed by 8 weeks haemodiafiltration

**Intervention Names:**

- Other: High-flux haemodialysis

- Procedure: Haemodiafiltration

**Label:** 8 weeks HF haemodialysis / 8 weeks HD-filtration

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 8 weeks haemodiafiltration followed by 8 weeks high-flux haemodialysis

**Intervention Names:**

- Other: High-flux haemodialysis

- Procedure: Haemodiafiltration

**Label:** 8 weeks HD-filtration /8 weeks HF haemodialysis

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 8 weeks HD-filtration /8 weeks HF haemodialysis

- 8 weeks HF haemodialysis / 8 weeks HD-filtration

**Description:** High-flux haemodialysis is the standard dialysis modality currently in use in the UK

**Name:** High-flux haemodialysis

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- 8 weeks HD-filtration /8 weeks HF haemodialysis

- 8 weeks HF haemodialysis / 8 weeks HD-filtration

**Description:** During Haemodiafiltration, the dialysis machine removes more water from the blood than during "normal" hemodialysis. The additional liquid is continually replaced with an ultra-pure solution. Thus, the machine exchanges a high volume of fluid during treatment and removes the liquid together with toxins from the blood.

**Name:** Haemodiafiltration

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Self-assessment by patient of hours/mins to full recovery after dialysis

**Measure:** Change in the average time taken to fully recover post dialysis

**Time Frame:** Baseline compared 8 week treatment point

#### Secondary Outcomes

**Measure:** Number of symptomatic hypotension events

**Time Frame:** Number of events noted by nurse at each dialysis session in each of the two arms of the study. Each arm= 3 sessions per week for 8 weeks

**Measure:** Number of dialysis circuit clotting events

**Time Frame:** Number of events noted by nurse at each dialysis session in each of the two arms of the study. Each arm= 3 sessions per week for 8 weeks

**Measure:** Pre-dialysis serum concentrations of potassium

**Time Frame:** Measured at baseline, and after 4 and 8 weeks of each treatment period

**Measure:** Pre-dialysis serum concentrations of phosphate

**Time Frame:** Measured at baseline, and after 4 and 8 weeks of each treatment period

**Measure:** Pre-dialysis serum concentrations of vitamin B12.

**Time Frame:** Measured at baseline, and after 4 and 8 weeks of each treatment period

**Measure:** Pre-dialysis serum concentrations of PTH.

**Time Frame:** Measured at baseline, and after 4 and 8 weeks of each treatment period

**Measure:** Pre-dialysis serum concentrations of beta-2-microglobulin

**Time Frame:** Measured at baseline, and after 4 and 8 weeks of each treatment period

**Measure:** Pre-dialysis serum concentrations of betaine

**Time Frame:** Measured at baseline, and after 4 and 8 weeks of each treatment period

**Measure:** Pre-dialysis serum concentrations of interleukin-6

**Time Frame:** Measured at baseline, and after 4 and 8 weeks of each treatment period

**Measure:** Kt/V urea.

**Time Frame:** : Measured at baseline, and after 4 and 8 weeks of each treatment period

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Receiving HF-HD for at least 3 months
* Reliable vascular access (i.e. use of the same fistula, graft or tunnelled central venous catheter for at least 1 month)
* Aged 18 or older

Exclusion Criteria:

* Currently receiving HDF
* Emergency hospital admissions within the preceding 4 weeks
* Life expectancy less than 6 months
* Neoplasia
* Unable to give informed consent
* Unable to perform QoL questionnaire or self report recovery post-dialysis time

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Glasgow

**Country:** United Kingdom

**Facility:** NHS Greater Glasgow andClyde

**Zip:** G12 0XH

#### Overall Officials

**Official 1:**

**Affiliation:** NHS Greater Glasgow and Clyde

**Name:** Robert MacTier, Md, FRCP

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10699

- Name: Kidney Failure, Chronic

- Relevance: HIGH

- As Found: End Stage Renal Disease

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007676

- Term: Kidney Failure, Chronic

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
