NCT06736184Not yet recruitingPhase 4
the Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients
A Prospective Multicenter Randomized Controlled Trial on the Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients
Source: ClinicalTrials.gov · Last updated 16 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The management of serum potassium in maintenance hemodialysis（MHD ）patients is one of the hot topics at present. In order to control hyperkalemia in dialysis patients, the use of hypokalemic dialysate is the most important measure to reduce potassium. This measure effectively reduces serum potassium, but increases the risk of hypokalemia after dialysis, which increases the risk of all-cause death in patients. Hyperkalemia and hypokalemia during and at the end of dialysis are important factors for arrhythmia and death in MHD patients. Due to the intermittent nature of hemodialysis treatment, MHD patients often experience frequent fluctuations in serum potassium, which is a potential risk factor for poor prognosis of MHD patients. Serum potassium variability can better reflect the potassium homeostasis in MHD patients. In addition to hyperkalemia and hypokalemia, serum potassium variability is a potential risk factor affecting the prognosis of MHD patients. At present, there are few studies on the effect of improving serum potassium variability on cardiovascular complications, especially multi-center randomized controlled trials. In this study, sodium zirconium cyclosilicate was used to control hyperkalemia before dialysis and increase potassium concentration in dialysate, so as to reduce the risk of hypokalemia after dialysis, and to verify whether improving serum potassium variability can reduce myocardial injury in hemodialysis patients.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 9 Dec 2024
- Start date
- 1 Mar 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Qianfoshan Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT06736184
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 1 Mar 2025 to the primary completion date, 31 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Complicated with congenital heart disease, myocardial infarction and other heart diseases that may lead to cardiac dysfunction;
- Combined with other serious diseases, such as immune diseases, severe liver and kidney dysfunction;
- If the duration of dialysis is less than 4 hours, severe infection;
- Patients with malignant tumors or major mental disorders;
- 6, except primary cardiomyopathy;
- 7\. Severe constipation, intestinal obstruction, etc.
- 8\. other investigators considered that enrollment was not recommended.
Other
- Unable to cooperate with the researcher due to mental reasons;
Who the study is looking for
- Age 18-75 years old;
- Maintenance hemodialysis ≥3 months;
- Serum potassium ≥5.0mmol/L and ≤8mmol/L before dialysis;
- Have independent ability;
- Complete clinical baseline data.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.