- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04182438
Low Potassium Content Vegetables in End-Stage Renal Disease
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hsuan-Jen Lin, MD
- Phone Number: +886976555706
- Email: beardogeli@gmail.com
Study Locations
-
-
-
Taichung, Taiwan, 413
- Recruiting
- Asia University Hospital
-
Contact:
- Hsuan-Jen Lin, MD
- Phone Number: +886976555706
- Email: beardogeli@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- End-Stage Renal Disease on chronic hemodialysis patients in single center
Exclusion Criteria:
- younger than 20 years old, the pregnant woman
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Low potassium then normal potassium
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.
|
use low-potassium content vegetables
|
EXPERIMENTAL: Normal potassium then low potassium
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.
|
use low-potassium content vegetables
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of serum potassium level
Time Frame: two weeks
|
Measure pre-dialysis serum potassium
|
two weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH108-REC3-136
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on End-stage Renal Disease
-
Outset MedicalCompletedAcute Kidney Injury | End Stage Renal Disease (ESRD) | End Stage Renal Disease on DialysisUnited States
-
University of Illinois at ChicagoWithdrawnObesity | End-Stage Renal Disease | Renal Disease, End-Stage | Renal Failure, End-StageUnited States
-
Bioconnect Systems, IncCompletedEnd-stage Renal Disease | End-stage Kidney DiseaseUnited States
-
Iperboreal Pharma SrlWithdrawnEnd-Stage Renal Disease
-
Cubist Pharmaceuticals LLCCompleted
-
Medical University of GrazWithdrawnEnd-stage Renal DiseaseAustria
-
Janssen Research & Development, LLCBayerCompleted
-
Chulalongkorn UniversityCompletedEnd-stage Renal DiseaseThailand
-
University of KansasCompletedEnd-Stage Renal Disease
-
Eisai Co., Ltd.CompletedEnd-Stage Renal DiseaseJapan
Clinical Trials on Low potassium content vegetables
-
Karolinska InstitutetKarolinska University HospitalCompletedHypertension | Cardiovascular DiseaseSweden
-
Edith Cowan UniversityFlinders University; The University of Western AustraliaCompleted
-
University of ManitobaDalhousie UniversityRecruitingChronic Kidney Disease | HyperkalemiaCanada
-
LHL HelseNorwegian University of Life Sciences; NIBIO - Norwegian Institute of Bioeconomy... and other collaboratorsCompletedObesity | Cardiovascular DiseaseNorway
-
Katherine BungeNational Institute of Allergy and Infectious Diseases (NIAID)CompletedSafety | AcceptabilityUnited States
-
Wageningen UniversityCompleted
-
Samuel Lunenfeld Research Institute, Mount Sinai...Completed
-
Oxford Brookes UniversitySuntory Beverage & Food LimitedCompleted
-
University of BolognaEuropean CommissionUnknown
-
Uppsala University HospitalHaukeland University Hospital; University Hospital, Linkoeping; Smerud Medical...UnknownIGA NephropathyNorway, Sweden