End-stage Renal Disease Clinical Trial
Official title:
Influence of Low Potassium Content Vegetables in End-Stage Renal Disease on Chronic Dialysis Patients
Hyperkalemia is common in End-Stage Renal Disease on chronic hemodialysis patients. The most
common cause of mortality in End-Stage Renal Disease patients is sudden cardiac death caused
by hyperkalemia. Hyperkalemia also increased urgent dialysis and hospitalization rate. Thus,
the management for hyperkalemia in End-Stage Renal Disease patients is crucial, including
restricting dietary potassium, medication control, and dialysis dosage adjustment. In the
ordinary diet, the significant sources of potassium are vegetables and fruit. In our study,
the investigators try to find out the influence of low potassium content vegetables for serum
potassium control in End-Stage Renal Disease on chronic hemodialysis patients.
This study is a prospective cohort study; the investigators enroll forty End-Stage Renal
Disease on hemodialysis patients and perform this study in eight weeks period. The
investigators conduct a randomized, double-blind and cross-over trial for investigating the
influence of low potassium content vegetables on End-Stage Renal Disease patients. The serum
potassium level will record under different potassium content vegetables. The possible
adverse effects of low potassium content vegetables, cardiac arrhythmia, will also obtain by
chart records during this study.
According to the plan moderator, after the patient agrees and signs the test consent form,
the patients will be randomly divided into two groups. The screening execution time of this
patient is expected to be 2 weeks. After randomization into two groups, the first group was
given low potassium content vegetables for 2 weeks, and the serum potassium level was
recorded during routine blood tests in the hemodialysis; then the normal potassium content
vegetables was given after 2 weeks of washing time. After 2 weeks of normal potassium content
vegetables, the serum potassium level was recorded during routine blood tests in the
hemodialysis, and the test was terminated. The second group was given normal potassium
content vegetables for 2 weeks, and the serum potassium level was recorded during routine
blood tests in the hemodialysis; after 2 weeks of washing time, the low potassium content of
the vegetables was given for 2 weeks. The serum potassium level was c, and the test was
terminated. Compare the potassium concentration of blood in hemodialysis patients using low
potassium vegetables with normal potassium content vegetables.
Routine blood test observed in this trial - including blood counts (white blood cells, red
blood cells, platelet count, hemoglobin, hematocrit), blood biochemical tests (including urea
nitrogen, creatinine, liver function, albumin, total protein, uric acid, electrolytes)
(sodium, potassium, calcium, phosphorus, magnesium, iron), iron storage protein, fasting
blood glucose, blood fat, parathyroid hormone concentration, dialysis parameters (artificial
kidney, weekly dialysis times, dialysis hours, dialysate concentration, dialysis volume) ,
dialysate temperature), and the patient's blood pressure changes and arrhythmia occurred
statistical analysis. Outpatient hemodialysis patients' medical records have been coordinated
with the hospital electronic data, data obtained from electronic medical records to obtain
patients with hypokalemia drugs or hypertension drug use records, dialysis records. All the
information obtained will be linked to ensure patient privacy.
During the trial, if the patient has hospitalization for arrhythmia caused by hypokalemia,
the record will be withdrawn from the trial and then withdrawn from the clinical trial and
excluded from the statistical analysis.
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