Metabolic Acidosis and Its Impact on Mineral Metabolism and Physical Performance in Renal Transplant Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Correction of metabolic acidosis
研究概览
简要总结
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
- to determine the status of physical capacity and bone structure in renal transplant patients with metabolic acidosis
- to study the effect of substituting base equivalents (citrate) on acid/base status of renal transplant patients with acidosis
- to compare the status of physical capacity and bone structure in renal transplant patients with metabolic acidosis before and after substitution with citrate
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a renal graft having been transplanted within the previous 8 years and being at least 3 months post transplantation, or, patients scheduled to undergo transplantation from a living organ donor within the upcoming 3 months
- •Venous serum bicarbonate concentration < 24 mmol/L at time of baseline determination
- •Renal transplant function with a calculated glomerular filtration rate (GFR) greater or equal 30 ml/min according to the Cockcroft-Gault formula
- •Immunosuppressive therapy including a calcineurin inhibitor (cyclosporine A or tacrolimus)
- •Age 20 through 65 years of either sex
- •Written informed consent for study participation
排除标准
- •Acute rejection episode requiring specific therapy within 4 weeks before study inclusion
- •Severe impairment in general health and/or physical handicaps (malignant neoplasia, catabolic state, acute systemic infection requiring therapy)
- •Mental illness, psychiatric disorder
- •Tetracycline intolerance
- •Planned or "overt" pregnancy
研究组 & 干预措施
Postassium citrate
Aim: correction of metabolic acidosis
干预措施: Potassium citrate (Drug)
Potassium chloride
Potassium chloride is given to compensate for any possible effects of potassium in potassium citrate (primary treatment).
干预措施: Potassium chloride (Drug)
结局指标
主要结局
Correction of metabolic acidosis
时间窗: 12 months
次要结局
- Improvement in physical capacity(12 months)