Kidney-protective Intervention With Salt Substitute After Kidney Tumor Surgery (NCT07062952) | Clinical Trial Compass
RecruitingNot Applicable
Kidney-protective Intervention With Salt Substitute After Kidney Tumor Surgery
China200 participantsStarted 2025-04-24
Plain-language summary
This clinical trial is an open-label, randomized controlled study designed to evaluate the efficacyand safety of salt substitutes in protecting renal function after kidney tumor surgery, aiming toprovide dietary renal protection strategies for postoperative kidney tumor patients. lt will alsoassess the feasibility of salt substitute intervention. The primary research questions are:
1. Does a salt substitute diet significantly improve estimated glomerular filtration rate (eGFR) compared to a regular salt diet in postoperative kidney tumor patients?
2. What is the safety profile of salt substitute intervention in postoperative kidney tumor patients?
3. What is the compliance rate among postoperative kidney tumor patients using saltsubstitutes?
4. ls the salt substitute intervention feasible?
Researchers will compare the intervention group (salt substitute diet) with the control group (regular salt diet) to determine whether salt substitutes effectively improve postoperative eGFR in kidney tumor patients.
Participants will be required to:
1. Consume salt substitutes or regular salt daily while strictly adhering to WHO-recommendedsalt intake levels for 1 year.
2. Undergo scheduled baseline assessments at 1, 3, 6, and 12 months post-surgery, with 24-hoururine tests at months 1 and 6 to evaluate compliance.
3. Receive regular monitoring of blood electrolytes, eGFR, and other renal function indicators.
4. Document any adverse events or health status changes during the study period.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntary participation with signed informed consent from both the primary participant and all cohabiting family members, with commitment to study procedures and follow-up;
✓. Age ≥18 years at enrollment (when signing informed consent), any gender;
✓. Diagnosed kidney tumor patients who underwent radical nephrectomy or partial nephrectomy (no restrictions on surgical approach);
✓. Preoperative eGFR \>60 ml/min/1.73m² (calculated by CKD-EPI equation);
✓. Serum potassium \<4.8 mmol/L;
✓. Predominantly home-based dietary habits (\>90% meals prepared at home, assessed via self-report);
✓. Normal contralateral renal function at screening;
✓. Normal cardiopulmonary and hepatic function:
Exclusion criteria
✕. Participant or cohabiting family members currently using potassium-sparing diuretics or potassium supplements, or prior use of salt substitutes;