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.

Phase 3

Completed

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

• Registration Number: CTRI/2017/12/010735
• Lead Sponsor: Christian medical college

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-09-22
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1.Patients on thrice weekly maintenance hemodialysis

2.Duration of HD for at least 6 weeks.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interdialytic weight gainTimepoint: At each dialysis session

Secondary Outcome Measures

Name	Time	Method
Blood Pressure (pre- and post-dialysis, systolic and diastolic) <br/ ><br>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