- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Tanta, Egypt
- Tanta University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Placebo komparator: control group
The control group will receive standard treatment.
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The control group will receive standard treatment.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Nutritional status of hemodialysis patients by anthropometric measurements weight (Kg ) , Height (m2), body mass index
Tidsramme: 3 weeks
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3 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
malnutrition inflammation score
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 36264MS509/2/24
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
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