| Trial ID: | L0858 |
| Source ID: | NCT02692378
|
| Associated Drug: |
Sodium Bicarbonate 500mg Capsules
|
| Title: |
Effects of Oral Sodium Bicarbonate Supplementation in Haemodialysis Patients (BicHD)
|
| Acronym: |
BicHD
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End-stage Renal Disease
|
| Interventions: |
DRUG: sodium bicarbonate 500mg capsules
|
| Outcome Measures: |
Primary: pre dialysis potassium level and intradialytic potassium gradient, Measurements over the first 4 weeks to establish blood potassium profile. Measurements over weeks 5-8 to detect early blood changes. Measurement over weeks 13-16 to detect late blood changes., 12 weekly blood tests over a period of 16 weeks | Secondary: 12 lead Electrocardiogram analysis, Electrocardiogram analysis before and after dialysis for the measurement of QT dispersion. Increase of the QT dispersion is linked to risk of ventricular arrhythmias., 3 timepoints (weeks 4, 8 and 16) over a period of 16 weeks|Total body muscle mass, Body composition measurement before dialysis with the validated body composition monitor by Fresenius, 2 timepoints (weeks 4 and 16) over a period of 16 weeks|Handgrip strength, Handgrip strength to measure muscle function. Measured before dialysis with the ®Jamar handgrip dynamometer., 2 timepoints (weeks 4 and 16) over a period of 16 weeks|Symptom severity, Haemodialysis related symptoms measured by a validated palliative outcome symptom scale-renal questionnaire (POS-S), 3 timepoints (weeks 4,8 and 16) over a period of 16 weeks
|
| Sponsor/Collaborators: |
Sponsor: Imperial College Healthcare NHS Trust | Collaborators: National Institute for Health Research, United Kingdom
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
44
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
|
| Start Date: |
2015-11
|
| Completion Date: |
2016-05
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-03
|
| Locations: |
Imperial College Healthcare NHS Trust, London, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT02692378
|
