Sodium Dialysate Concentration for Chronic Kidney Failure

(RESOLVE Trial)

Recruiting at 294 trial locations

Overseen By Grace Balicki

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Sydney

Disqualifiers: Non-compliance with data collection

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2-5 years

50000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major cardiovascular events and death in patients receiving maintenance haemodialysis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is sodium dialysate concentration safe for humans?

Sodium dialysate concentration in hemodialysis is generally considered safe, but it can have different effects depending on the concentration used. Lower concentrations may reduce weight gain and high blood pressure but can increase the risk of low blood pressure and cramps, while higher concentrations may stabilize blood pressure but increase thirst and fluid retention. Safety can vary based on individual needs, so it's important to tailor the concentration to each person. ^{1 2 3 4 5}

How does the treatment using different sodium dialysate concentrations for chronic kidney failure differ from other treatments?

This treatment is unique because it involves adjusting the sodium concentration in the dialysate (the fluid used in dialysis) to either 137 mmol/l or 140 mmol/l, which can influence blood pressure and fluid retention differently. Unlike standard treatments, this approach considers individual patient needs and aims to balance the benefits of reducing fluid overload and hypertension with the risk of low blood pressure and cramps during dialysis. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment Sodium Dialysate Concentration for Chronic Kidney Failure?

Research suggests that lower dialysate sodium concentrations (134 to 138 mEq/L) may help reduce weight gain between dialysis sessions and improve blood pressure control, while higher concentrations may benefit patients with low blood sodium levels by preventing low blood pressure during treatment. However, the best concentration may vary for each patient, and there is no universal agreement on the ideal level. ^{1 2 4 5 7}

Who Is on the Research Team?

Sunita Bavanandan

Principal Investigator

Kuala Lumpur General Hospital

Vivekanand Jha

Principal Investigator

The George Institute India

Zuo Li

Principal Investigator

Peking University People's Hospital

David Wheeler

Principal Investigator

Comprehensive Clinical Trials Unit, University College London

Patrick Rossignol

Principal Investigator

INSERM Clinical Investigation Centre

Mike Walsh

Principal Investigator

McMaster University

Vlado Perkovic

Principal Investigator

University of New South Wales

Christoph Wanner

Principal Investigator

University Hospital Wuerzburg

Jule Pinter

Principal Investigator

University Hospital Wuerzburg

Meg Jardine

Principal Investigator

The University of Sydney, NHMRC Clinical Trials Centre

Carmel Hawley

Principal Investigator

The University of Queensland

Are You a Good Fit for This Trial?

This trial is for adults (18+) on maintenance hemodialysis for kidney failure at dialysis centers. Centers must be willing to use one of two standard salt levels in the dialysate, have low patient dropout rates, and not regularly rotate patients through different units. Home dialysis units are excluded.

Inclusion Criteria

My dialysis uses the standard salt level.

My treatment site does not focus on home dialysis training or support.

I have received dialysis at least 10 times before being considered for the study.

Exclusion Criteria

Not able to comply with data collection methods

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Dialysis sites are randomized to a default dialysate sodium concentration of 137mmol/l or 140mmol/l

2-5 years

Follow-up

Participants are monitored for major cardiovascular events and all-cause death

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Default dialysate sodium concentration of 137mmol/l
• Default dialysate sodium concentration of 140mmol/l

Trial Overview The study compares two common salt concentrations used during hemodialysis (140mmol/l vs. 137mmol/l) to see which is better at reducing heart problems and death in patients undergoing regular treatment for chronic kidney failure.

How Is the Trial Designed?

Group I: 137mmol/l Active Control 1 Intervention

Participating dialysis sites will be randomised to a default dialysate sodium concentration of 137mmol/l

Group II: 140mmol/l Active Control 1 Intervention

Participating dialysis sites will be randomised to a default dialysate sodium concentration of 140mmol/l

Who Is Running the Clinical Trial?

University of Sydney

Lead Sponsor

Trials

208

Recruited

417,000+

Peking University People's Hospital

Collaborator

Trials

657

Recruited

6,518,000+

Institute for Clinical Evaluative Sciences

Collaborator

Trials

37

Recruited

2,509,000+

St. Michaels Hospital

Collaborator

Trials

1

Recruited

50,000+

University Hospital Wuerzburg, Medizinische Klinik EINS

Collaborator

Trials

1

Recruited

50,000+

The George Institute

Collaborator

Trials

84

Recruited

275,000+

University of Wuerzburg

Collaborator

Trials

70

Recruited

77,600+

Malaysian Society of Nephrology

Collaborator

Trials

2

Recruited

50,100+

Malaysian Renal Registry

Collaborator

Trials

1

Recruited

50,000+

Comprehensive Clinical Trials Unit, University College London

Collaborator

Trials

1

Recruited

50,000+

Citations

1. Canada pubmed.ncbi.nlm.nih.gov

Why does the choice of dialysate sodium concentration remain controversial? [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of Prescribed and Measured Dialysate Sodium: A Quality Improvement Project. [2016]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Sodium fluxes during hemodialysis. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Audit of the effect of dialysate sodium concentration on inter-dialytic weight gains and blood pressure control in chronic haemodialysis patients. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Dialysate Sodium: Rationale for Evolution over Time. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Dialysate sodium control during modeling in hemodialysis. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical validation of a predictive modeling equation for sodium. [2019]