Sodium Dialysate Concentration for Chronic Kidney Failure

(RESOLVE Trial)

Recruiting at 313 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 trial examines how different sodium levels in dialysis fluid impact heart health and survival rates in individuals with chronic kidney failure undergoing regular dialysis. The trial will test two sodium levels, 137 mmol/l and 140 mmol/l, to determine which benefits patients more. Individuals currently receiving regular dialysis treatments and experiencing issues like heart problems may be suitable candidates for this trial. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, and this research aims to understand its benefits for a broader patient population.

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.

What is the safety track record for these treatments?

Research has shown that both 137mmol/l and 140mmol/l sodium levels in dialysis fluid are generally safe for people undergoing hemodialysis. Studies indicate that a sodium level of 137mmol/l can help reduce weight gain between dialysis sessions, which may benefit some patients. In contrast, a sodium level of 140mmol/l has been linked to fewer hospital visits and lower death rates in certain situations where it is commonly used. Both levels have been safely used in practice. This trial aims to understand how these sodium levels affect heart health and survival, but previous evidence suggests they are well-tolerated. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores the impact of adjusting dialysate sodium concentrations during dialysis for chronic kidney failure. While most dialysis treatments use a standard sodium concentration, this trial compares two different levels—137mmol/l and 140mmol/l—to see how they affect patient outcomes. By fine-tuning the sodium levels, researchers hope to improve fluid balance and reduce complications like hypertension. This could lead to more personalized and effective dialysis treatments, enhancing quality of life for patients with chronic kidney failure.

What evidence suggests that this trial's treatments could be effective for chronic kidney failure?

This trial will compare the effects of two different dialysate sodium concentrations for chronic kidney failure. Research has shown that a dialysate sodium level of 140mmol/l is linked to lower death rates compared to levels of 138mmol/l or less. This level also reduces hospital visits and improves survival in some dialysis situations. In contrast, a lower level, like 137mmol/l, does not significantly affect weight gain between dialysis sessions or blood pressure. While no clear difference in overall sodium balance exists between 140mmol/l and lower levels, evidence suggests better survival with 140mmol/l. Thus, the higher sodium level might be more effective in maintaining patient health during dialysis. Participants in this trial will be randomized to receive either the 137mmol/l or 140mmol/l sodium concentration to evaluate these outcomes. ^{1 2 3 6 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. clinicaltrials.gov clinicaltrials.gov/study/NCT02823821

Study Details | NCT02823821 | Randomised Evaluation of ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8212486/

Association between dialysate sodium concentration and ... Using a lower dialysate sodium concentration does not appear useful in altering the interdialytic weight gain or blood pressure.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10843180/

Are Observational Reports on the Association of Dialysate ... DNa levels >140 mmol/L were associated with lower hospitalizations and, in units practising a default approach, with lower all-cause mortality. The association ...

4. withpower.com withpower.com/trial/phase-4-kidney-diseases-5-2016-9c741

Sodium Dialysate Concentration for Chronic Kidney Failure This global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol/l ...

5. mdpi.com mdpi.com/2077-0383/12/13/4381

Recent Advances in Sodium Magnetic Resonance Imaging ... In this article, we have reviewed 23 Na MRI studies in CKD that demonstrate the association of sodium with hypertension, systemic inflammation, and ...

6. link.springer.com link.springer.com/article/10.1007/s11255-024-03972-3

Interdialytic weight gain and low dialysate sodium ... The present systematic review and meta-analysis aims to evaluate the efficacy of low dialysate sodium concentration in reducing IDWG in prevalent chronic ...

7. mdpi.com mdpi.com/2673-8236/2/2/31

Choosing a Dialysate Sodium Concentration for ... Observational and randomized studies reported lower dialysate sodium of 136–137 mmol/L, resulted in lower inter-dialytic weight gains compared to ≥140 mmol/L, ...