Effects of Intensified Sodium Management in Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary aim of this study is to investigate whether intensive sodium management by dietary sodium restriction and by preventing positive sodium balance during dialysis can be successfully applied in chronic hemodialysis patients. Secondary aims are to test if sodium restriction has positive effects on the frequency of hospital admissions, blood pressure, fluid overload, quality of life and residual renal function.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mechanisms and Treatment of Intradialytic Hypertension - Sodium

NCT01371890

Hemodialysis End-stage Renal Disease Hypertension +1 more

COMPLETED

Volume,Sodium and Blood Pressure Management in HD

NCT01766882

End Stage Renal Failure

COMPLETED NA

Dialysate Sodium Lowering Trial

NCT03144817

Hemodialysis Complication Fluid Overload Dialysis Disequilibrium +2 more

COMPLETED PHASE2

Effects of Simple Sodium Alignment on Clinical Outcomes

NCT01825590

Complication of Hemodialysis

COMPLETED

Reducing Dialysate Sodium Effect on Blood Pressure Variability in Hemodialysis Patients

NCT05169125

Hemodialysis Patients

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Failure Chronic Requiring Hemodialysis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intensive sodium management

Group Type EXPERIMENTAL

intensive sodium management

Intervention Type OTHER

1. dietary sodium restriction
2. avoiding positive sodium balance during dialysis by: aligning dialysate sodium with plasma sodium, avoiding sodium profiling, and avoiding saline solutions to treat intradialytic symptoms

standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

intensive sodium management

1. dietary sodium restriction
2. avoiding positive sodium balance during dialysis by: aligning dialysate sodium with plasma sodium, avoiding sodium profiling, and avoiding saline solutions to treat intradialytic symptoms

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ambulatory, clinically stable maintenance hemodialysis patients on a thrice weekly HD regimen.
* Willing and able to provide written, signed informed consent after the nature of the study has been explained.
* Willing and able to comply with all study procedures.
* Age ≥18 years.

Exclusion Criteria

* Simultaneous participation in another clinical study except observational trials.
* Any psychological condition which could interfere with the patient's ability to comply with the study protocol.
* Pregnancy.
* Amputation of a limb.
* Pacemaker, implantable pump, artificial joint.
* Expectation that native kidney function will recover.
* Unable to verbally communicate in English or Spanish.
* Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center within the next 14 months.
* Life expectancy \< 15 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No