Nutritional Education on Control of Serum Potassium Level in Maintenance Hemodialysis Patients

Effect of Nutritional Education on Control of Serum Potassium Level in Maintenance Hemodialysis Patients

The aims of the present study are to determine how face-to-face nutrition education about potassium will affect serum Potassium levels and reduce its complications and improve quality of life for Maintenance Hemodialysis patients at Internal Medicine Department, Tanta University Hospitals.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; Potassium Measurement; Maintenance Dialysis Patients
• Intervention / Treatment: Behavioral: The education group; Behavioral: The control group

Detailed Description

Nutrition program on patients with chronic renal failure and receiving dialysis plays an important role in the process of treatment1.The purposes of medical nutrition therapy in dialysis patients are to correct patients' appetite, to relieve or prevent the cardiovascular, cerebrovascular, peripheral vascular complications, to prevent increasing fluid accumulations and to ensure optimum nutrition. In addition, medical nutrition helps to control potassium, sodium, and other electrolytes balance.

Potassium (K+) is the most common cation in the body that plays a role in vital functions such as inter-cellular communication, muscle contraction, displacement of fluids between the body parts, transmission of impulses, and release of hormones. Potassium, which is taken into the human body by diet or by other ways like: drugs (beta-blocking agents, angiotensin II receptor blockers, angiotensin-converting enzyme inhibitors and non-steroidal anti-inflammatory drugs), food additives, nutritional supplements, etc., is removed by the kidneys or intestines4. The amount of potassium excretion in hemodialysis treatment is 10% lower than the normal physiological process. The most practical and safe way to compensate for this decrease is to reduce the amount of potassium taken with diet.

In hemodialysis patients, Hyperkalemia is a life-threatening complication. Serum potassium is frequently monitored and managed to maintain its values between 3.5 and 5.5 mmol/L6. Due to impaired renal excretion, these patients are more prone to developing hyperkalemia, therefore, suffer its consequences that is range from, nausea, fatigue, abdominal cramping, paresthesia, and muscle weakness, to severe hyperkalemia (≥6.5 mmol/L) that can cause alterations in cardiac physiology, leading to chest pain, shortness of breath, and sudden cardiac arrest. Both hypo- and hyperkalemia can cause fatal cardiac arrhythmias.

Therefore, different guidelines suggest that patients should restrict their dietary potassium intake to 2-2.5 g per day. However, the benefits of this practice are entirely theoretical and not supported by randomized controlled trials. The hypothesis that potassium restriction is useful is based on that assumption of different sources of dietary potassium are therapeutically equivalent. These restrictions may limit protein intake, exacerbating malnutrition, inflammation, atherosclerosis and increase mortality among hemodialysis patients. In fact, animal and plant sources of potassium may differ in their potential to contribute to hyperkalemia.

Nutrition educations specific to this situation or nutrients improve individuals' knowledge of the subject and positively affect their adherence with the diet. One of the nutrition educations that should be given to patients receiving hemodialysis should be about the amount of potassium intake with diet. During this, patients should be informed about the importance of nutrition in hemodialysis treatment, the potassium content of foods. effects of some cooking methods on the reduction of the potassium content of foods, and on serum potassium levels.

This study will be carried out to assess the effect of short-term intensive renal nutritional education on the control of serum potassium level. Using the Egyptian Potassium Pyramids, followed by performance of nutritional and anthropometric measurements in maintenance HD patients.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult older than 18 years of both sex.
• Individuals had been undergoing hemodialysis at least three times a week for more than six months.
• Individuals have a serum potassium level ≥5.5 mEq/L.
• Able to provide an informed consent.
• Willingness to adhere to the study protocol for its entire duration.
• Absence of any planned medical procedures that might interfere with study participation during the study period.

Exclusion Criteria:

• Individuals who had received education on potassium previously. Patients who took potassium-lowering drugs.
• Individuals whose serum potassium level was below 5.5 mEq/L during the month before the study.
• Presence of Cardiovascular complications or any event from multiple co-morbid metabolic diseases like pulmonary edema, congestive heart failure, or coma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The education group; The education group will undergo a 12-week nutritional education program	Behavioral: The education group; The education group will undergo a 12-week nutritional education program
Placebo Comparator: control group; The control group will receive standard treatment.	Behavioral: The control group; The control group will receive standard treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Nutritional status of hemodialysis patients by anthropometric measurements weight (Kg ) , Height (m2), body mass index	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
malnutrition inflammation score	The assessment evaluates 10 distinct components. Each component is graded on a scale of 0 (normal) to 3 (severely abnormal)	3 weeks

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Hemodialysis; Maintenance; Control; Nutritional Education
• Other Study ID Numbers: 36264MS509/2/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It will be available if it needed
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No