The effect of acidosis correction and exercise on tissue wasting and immune function in renal patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006948-65-GB

Enrollment

Registered

2007-01-26

Start date

2007-11-29

Completion date

Unknown

Last updated

2020-10-13

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

Conditions

Chronic kidney disease

Interventions

Trade Name: Sodium bicarbonate 500mg capsules Product Name: Sodium bicarbonate Pharmaceutical Form: Capsule, hard

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Chronic kidney disease patients at CKD stages 4 to 5 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Physical disability sufficient to preclude participating in an exercise programme Age less than 18 years Pregnancy Congestive heart failure Live cirrhosis The Summary of Product Characteristics also recommends caution in the use of sodium bicarbonate in those with impaired renal function , hypertension, and dietary sodium restriction. These features characterise all subjects recruited to this study. Due caution will be exercised based on the expert clinical knowledge and experience of the investigators.

Design outcomes

Primary

Measure	Time frame
Main Objective: The interaction between exercise and metabolic acidosis in chronic kidney disease has never been investigated. Important questions to be answered are: • What influence does correcting acidosis have on exercise tolerance? • Are the expected beneficial effects of exercise and acidosis correction additive? OR • Does exercise (which generates lactic acid in muscle) worsen the acidosis problem? This may be important in kidney patients because the level of exercise needed to generate lactic acid (the lactate threshold) is low. • Does correcting acidosis allow an improved response to exercise in those kidney patients who currently respond poorly to exercise therapy alone? ;Secondary Objective: ;Primary end point(s): Muscle mass and ability to perform exercise Signals in muscle which control protein synthesis Blood pressure, pulse wave velocity, finometry Quality of life using Leicester uraemic symptoms score	—

Measure

Time frame

Main Objective: The interaction between exercise and metabolic acidosis in chronic kidney disease has never been investigated. Important questions to be answered are: • What influence does correcting acidosis have on exercise tolerance? • Are the expected beneficial effects of exercise and acidosis correction additive? OR • Does exercise (which generates lactic acid in muscle) worsen the acidosis problem? This may be important in kidney patients because the level of exercise needed to generate lactic acid (the lactate threshold) is low. • Does correcting acidosis allow an improved response to exercise in those kidney patients who currently respond poorly to exercise therapy alone? ;Secondary Objective: ;Primary end point(s): Muscle mass and ability to perform exercise Signals in muscle which control protein synthesis Blood pressure, pulse wave velocity, finometry Quality of life using Leicester uraemic symptoms score

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Countries

United Kingdom

Outcome results

None listed

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