Metabolic Acidosis Clinical Trial
Official title:
Metabolic Acidosis and Its Impact on Mineral Metabolism and Physical Performance in Renal Transplant Patients
Acidosis (accumulation of acid in the body) may be an underrecognized problem in patients
after renal transplantation. It may have consequences on physical performance due to
negative effects on bone and muscle metabolism.
Therefore, the purpose of this study is
1. to determine the status of physical capacity and bone structure in renal transplant
patients with metabolic acidosis
2. to study the effect of substituting base equivalents (citrate) on acid/base status of
renal transplant patients with acidosis
3. to compare the status of physical capacity and bone structure in renal transplant
patients with metabolic acidosis before and after substitution with citrate
Chronic kidney disease is developing to become one of the major health problems in the
Western world with more than one million patients on renal replacement therapy, and many
more expected in the years ahead [1]. Survival of patients with end stage renal disease has
become possible with the introduction of dialysis therapy. Renal transplantation has
resulted both in further reduction of mortality and improvement in quality of life for
patients with end stage renal disease. Nevertheless, successful transplantation with regard
to graft and patient survival is still associated with significant morbidity. Apart from
infectious complications and cardiovascular disease, limitations in physical capacity from
musculoskeletal disorders have become a relevant problem, resulting in reduced quality of
life, poor physical functioning and inability to work.
Muscle and bone metabolism in chronic kidney disease are typically disturbed resulting in
significant pathology and dysfunction of the affected tissues. They are associated with
metabolic disorders related to renal insufficiency, among which metabolic acidosis is a
major contributor. Metabolic acidosis is a well recognized problem in renal transplant
patients. However, its prevalence, pathogenesis, course and sequelae are not well
established. In particular, its relation to post-transplant bone and muscle disorders, and
the impact on physical capabilities in renal transplant patients have not been
comprehensively investigated so far.
The purpose of the proposed project is to examine the characteristics and pathogenesis of
post-transplant metabolic acidosis, and its relation to bone and muscle pathologies and
impact on physical capabilities in renal transplant patients. In particular, the following
aims are proposed to investigate in de novo and long-term renal transplantation:
Aim # 1: To examine the type, degree and course of metabolic acidosis in renal transplant
patients, early and long-term after transplantation
Aim # 2: To examine alterations in mineral and bone metabolism, and bone structure, and
their relationship to the acid/base disorder
Aim # 3: To examine overall physical performance, exercise capacity and muscle energy
content, and their relationship to the acid/base disorder
In order to analyze secondary effects of subclinical and overt acidosis on bone (Aim # 2)
and muscle (Aim # 3), patients will be studied at baseline, and then be supplemented with
base equivalents in order to achieve a stable plasma serum bicarbonate concentration of
24-26 mmol/l, and be reexamined thereafter. Completion of the three aims will allow to
comprehensively analyze the pathogenesis of and interrelations between acid/base status,
mineral metabolism, bone disorders and muscle function in renal transplant patients. This
will be the first study to link metabolic alterations to structural and functional measures
of the musculoskeletal system, and to the impact of the resulting pathologies on physical
disabilities in patients with a kidney graft. We are in dire need to know the magnitude of
the problem, whether to treat, and how aggressive to treat these patients. The results of
this project will be indispensable regarding justification to rigorously evaluate and treat
metabolic acidosis in patients with chronic renal insufficiency and after transplantation.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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