To study the blood levels of sodium in patients undergoing hemodialysis and see if adjusting the dialysis fluid sodium levels will have any effect on weight gain, blood pressure and adverse events during dialysis in these patients.

A study on the profile of sodium set point in patients undergoing hemodialysis and the effect of sodium profiling on weight gain, blood pressure and intradialytic complications.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010735

Enrollment

Registered

2017-12-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic kidney disease stage 5, on maintenance hemodialysis

Interventions

Intervention1: Individualised dialysate sodium: Setting the sodium level in dialysate based on each patients pre-hemodialysis sodium level Control Intervention1: Standard dialysate sodium: Dialysate s

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients on thrice weekly maintenance hemodialysis 2.Duration of HD for at least 6 weeks.

Exclusion criteria

Exclusion criteria: 1.Expected life expectancy less than 6 months 2.Pre-HD sodium less than 130 meq/L or >140 meq/L at recruitment 3.Scheduled for live donor kidney transplant within 2 months of enrolment 4.Considered by the treating nephrologist to have concomitant illnesses or conditions that limit or contraindicate study procedures and follow-up (e.g. frequent intra-dialytic hypotension requiring fluid resuscitation) 5.Documented infiltrative cardiomyopathies, (amyloid, glycogen storage disease), hereditary cardiomyopathies (hypertrophic cardiomyopathy) or moderate to severe aortic valve disease (aortic stenosis, regurgitation) 6.Amputees 7.Failure to give informed consent 8.Pseudohyponatremia

Design outcomes

Primary

Measure	Time frame
Interdialytic weight gainTimepoint: At each dialysis session	—

Secondary

Measure	Time frame
Blood Pressure (pre- and post-dialysis, systolic and diastolic) Timepoint: At each dialysis session;Hemodialysis-related adverse events including cramps, nausea, vomitingTimepoint: At each dialysis session;IDWG% (calculated by dividing the IDWG (Interdialytic weight gain) by the dry weight multiplied by 100)Timepoint: At each dialysis session;Interventions during HDTimepoint: At each dialysis session;Intradialytic hypotension (IDH)Timepoint: At each dialysis session;Thirst scoreTimepoint: At each dialysis session;Ultrafiltration (UF) rate (mL/hour/kg) (calculated by dividing UF volume by the length of treatment in hours divided by post-HD weight)Timepoint: At each dialysis session	—

Measure

Time frame

Blood Pressure (pre- and post-dialysis, systolic and diastolic) Timepoint: At each dialysis session;Hemodialysis-related adverse events including cramps, nausea, vomitingTimepoint: At each dialysis session;IDWG% (calculated by dividing the IDWG (Interdialytic weight gain) by the dry weight multiplied by 100)Timepoint: At each dialysis session;Interventions during HDTimepoint: At each dialysis session;Intradialytic hypotension (IDH)Timepoint: At each dialysis session;Thirst scoreTimepoint: At each dialysis session;Ultrafiltration (UF) rate (mL/hour/kg) (calculated by dividing UF volume by the length of treatment in hours divided by post-HD weight)Timepoint: At each dialysis session

—

Countries

India

Contacts

Public ContactRadhika C R

Christian Medical College, Vellore

santosh.vellore@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026