Low Potassium Content Vegetables in End-Stage Renal Disease

End-stage Renal Disease Clinical Trial

Official title:

Influence of Low Potassium Content Vegetables in End-Stage Renal Disease on Chronic Dialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04182438
• Other study ID #: CMUH108-REC3-136
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: February 29, 2020

Study information

• Verified date: January 2020
• Source: China Medical University Hospital
• Contact: Hsuan-Jen Lin, MD
• Phone: +886976555706
• Email: beardogeli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• End-Stage Renal Disease on chronic hemodialysis patients in single center

Exclusion Criteria:

• younger than 20 years old, the pregnant woman

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Dietary Supplement:
• Low potassium content vegetables
use low-potassium content vegetables

Locations

Country	Name	City	State
Taiwan	Asia University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of serum potassium level	Measure pre-dialysis serum potassium	two weeks