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Electrolyte

Sodium Dialysate Concentration for Chronic Kidney Failure (RESOLVE Trial)

Phase 4

Recruiting

Led By Jule Pinter

Research Sponsored by The George Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a minimum of 10 dialysis recipients at time of randomisation

Predominantly dialyses adults (≥18 years old) receiving maintenance haemodialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through to study completion (estimated to occur after an average of 5 years follow up)

Awards & highlights

RESOLVE Trial Summary

This trial will study whether a lower concentration of sodium in dialysis fluid can reduce the risk of cardiovascular events and death in patients receiving maintenance dialysis.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the trial itself does not introduce new medications with side effects, changes in dialysate sodium may affect blood pressure, thirst, fluid retention or cause discomfort during or after dialysis sessions.

RESOLVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am an adult on regular dialysis treatment.

RESOLVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through to study completion (estimated to occur after an average of 5 years follow up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through to study completion (estimated to occur after an average of 5 years follow up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through to study completion (estimated to occur after an average of 5 years follow up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to first occurrence of an event in the primary composite outcome

Secondary outcome measures

Time to first occurrence of an event in the secondary composite outcome

Time to first occurrence of each of the individual components of the composite outcomes.

RESOLVE Trial Design

2Treatment groups

Active Control

Group I: 137mmol/lActive Control1 Intervention

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

Group II: 140mmol/lActive Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Peking University People's HospitalOTHER

570 Previous Clinical Trials

6,406,199 Total Patients Enrolled

Institute for Clinical Evaluative SciencesOTHER

36 Previous Clinical Trials

2,459,099 Total Patients Enrolled

1 Trials studying Kidney Failure

26 Patients Enrolled for Kidney Failure

St. Michaels HospitalUNKNOWN

Media Library

Default dialysate sodium concentration of 137mmol/l (Electrolyte) Clinical Trial Eligibility Overview. Trial Name: NCT02823821 — Phase 4

Kidney Failure Research Study Groups: 137mmol/l, 140mmol/l

Kidney Failure Clinical Trial 2023: Default dialysate sodium concentration of 137mmol/l Highlights & Side Effects. Trial Name: NCT02823821 — Phase 4

Default dialysate sodium concentration of 137mmol/l (Electrolyte) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02823821 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this experiment ongoing for volunteers?

"Yes, this clinical trial is actively recruiting participants. The details were first published on June 1st 2016 before being updated most recently on October 6th 2022. In total, 50 thousand individuals must be recruited from 20 different medical centres."

Answered by AI

How many participants are included in the current recruitment for this research endeavor?

"Affirmative. The information published on clinicaltrials.gov verifies that this trial, which was initially posted June 1st 2016, is actively recruiting subjects. Approximately 50,000 persons are being sought from 20 different medical centres."

Answered by AI

Has the FDA greenlighted a 140mmol/l concentration?

"We rate the safety of 140mmol/l at a 3, seeing as it has been approved for Phase 4 and thus has multiple data sets that attest to its security."

Answered by AI

How widespread is the implementation of this research endeavor?

"St. Michael's Hospital in Toronto, Picton in Stratford, and Huron Perth Hospital Partnership in Owen Sound are just some of the 20 sites running this medical trial."

Answered by AI

Recent research and studies

Current Opinion in Nephrology & HypertensionJournal

Volume Management in Haemodialysis Patients

See, Emily J., and Kevan R. Polkinghorne. 2020. “Volume Management in Haemodialysis Patients”. Current Opinion in Nephrology & Hypertension. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mnh.0000000000000642.

clinicaltrials.govStudy

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

2016. "Randomised Evaluation of Sodium Dialysate Levels on Vascular Events". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02823821.