- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07632105
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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tanta, Egipto
- Tanta University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: The education group
The education group will undergo a 12-week nutritional education program
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The education group will undergo a 12-week nutritional education program
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Comparador de placebos: control group
The control group will receive standard treatment.
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The control group will receive standard treatment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Nutritional status of hemodialysis patients by anthropometric measurements weight (Kg ) , Height (m2), body mass index
Periodo de tiempo: 3 weeks
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3 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
malnutrition inflammation score
Periodo de tiempo: 3 weeks
|
The assessment evaluates 10 distinct components.
Each component is graded on a scale of 0 (normal) to 3 (severely abnormal)
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3 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 36264MS509/2/24
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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