search
Back to results

Low Potassium Content Vegetables in End-Stage Renal Disease

Primary Purpose

End-stage Renal Disease

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Low potassium content vegetables
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for End-stage Renal Disease focused on measuring Low potassium content vegetables, End-Stage Renal Disease, Hemodialysis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • younger than 20 years old, the pregnant woman

Sites / Locations

  • Asia University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low potassium then normal potassium

Normal potassium then low potassium

Arm Description

After giving the vegetables with low potassium content vegetables for 2 weeks, the serum potassium level was recorded; after 2 weeks of washing time, the normal potassium content vegetables was given for 2 weeks, and the serum potassium concentration was recorded and the test was terminated.

After giving the normal potassium content vegetables for 2 weeks, the serum potassium concentration was recorded; after 2 weeks of washing time, the low potassium content vegetables use for 2 weeks, then the serum potassium level was recorded at the time. The test was terminated.

Outcomes

Primary Outcome Measures

Change of serum potassium level
Measure pre-dialysis serum potassium

Secondary Outcome Measures

Full Information

First Posted
November 26, 2019
Last Updated
January 2, 2020
Sponsor
China Medical University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04182438
Brief Title
Low Potassium Content Vegetables in End-Stage Renal Disease
Official Title
Influence of Low Potassium Content Vegetables in End-Stage Renal Disease on Chronic Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
February 29, 2020 (Anticipated)
Study Completion Date
February 29, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
Keywords
Low potassium content vegetables, End-Stage Renal Disease, Hemodialysis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study will enroll 40 End-Stage Renal Disease on chronic hemodialysis patients. We will perform a randomized, double-blind, cross over study. In one group, low potassium content vegetables use as study intervention for two weeks (study phase), then shift to placebo (ordinary vegetables) for two weeks. In another group, ordinary vegetables will use firstly, then change to low potassium content vegetable use. Serum potassium, blood pressure, and biochemistries will analyze at the end of the study.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low potassium then normal potassium
Arm Type
Experimental
Arm Description
After giving the vegetables with low potassium content vegetables for 2 weeks, the serum potassium level was recorded; after 2 weeks of washing time, the normal potassium content vegetables was given for 2 weeks, and the serum potassium concentration was recorded and the test was terminated.
Arm Title
Normal potassium then low potassium
Arm Type
Experimental
Arm Description
After giving the normal potassium content vegetables for 2 weeks, the serum potassium concentration was recorded; after 2 weeks of washing time, the low potassium content vegetables use for 2 weeks, then the serum potassium level was recorded at the time. The test was terminated.
Intervention Type
Dietary Supplement
Intervention Name(s)
Low potassium content vegetables
Intervention Description
use low-potassium content vegetables
Primary Outcome Measure Information:
Title
Change of serum potassium level
Description
Measure pre-dialysis serum potassium
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: End-Stage Renal Disease on chronic hemodialysis patients in single center Exclusion Criteria: younger than 20 years old, the pregnant woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsuan-Jen Lin, MD
Phone
+886976555706
Email
beardogeli@gmail.com
Facility Information:
Facility Name
Asia University Hospital
City
Taichung
ZIP/Postal Code
413
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsuan-Jen Lin, MD
Phone
+886976555706
Email
beardogeli@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Low Potassium Content Vegetables in End-Stage Renal Disease

We'll reach out to this number within 24 hrs