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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:
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:
Patients after kidney tumor surgery (radical nephrectomy or partial nephrectomy) experience acute loss of functional nephrons, causing compensatory hyperfunction in remaining nephrons under overload conditions. This manifests as elevated glomerular filtration rate (hyperfiltration), increased plasma flow (hyperperfusion), and heightened capillary transmembrane pressure (hypertension), collectively termed the "three-high glomerular state," significantly increasing risks of Acute Kidney Injury(AKI) and long-term Chronic Kidney Disease(CKD). Chinese populations consume salt far exceeding WHO recommendations, with proven associations to hypertension, stroke, cardiovascular disease, kidney disease, and gastric cancer. High salt intake elevates CKD risk through two pathways: chronic high salt consumption induces hypertension (a key CKD risk factor), and activates renal renin-angiotensin-aldosterone system (RAAS), promoting inflammation, fibrosis, and oxidative stress-induced kidney damage-exacerbating the postoperative "three-high state" and further increasing CKD risk. Additionally, Asian populations frequently carry salt-sensitive genetic variants, where both salt sensitivity and high intake cause mineralocorticoid receptor overactivation, independently amplifying CKD susceptibility. Salt substitutes (potassium-enriched low-sodium salt, primarily NaCl and KCl) reduce sodium content versus regular salt, potentially improving renal hemodynamics by lowering sodium load and supplementing potassium to delay renal function decline. Recent multicenter RCTs and meta-analyses confirm cardiovascular benefits: the SSaSS trial demonstrated 13% reduced cardiovascular event risk with potassium-enriched salt (25% KCl), preventing ~460,000 cardiovascular deaths annually via blood pressure control and ~743,000 non-fatal cardiovascular events (including ~120,000 CKD cases) without significant hyperkalemia-related adverse events. The DECIDESalt trial showed significant blood pressure reductions (SBP: -7.1 mmHg; DBP: -1.9 mmHg) and lower cardiovascular risk with salt substitutes versus regular salt, with post hoc analysis indicating reduced hypertension incidence in normotensive individuals without inducing hypotension. Meta-analyses highlight amplified benefits in high-risk populations and Asian diets via sodium-potassium homeostasis and vascular improvement, with clinically insignificant mild potassium elevation confirming efficacy and safety. Despite these cardiovascular benefits, salt substitutes' renal safety and efficacy in post-nephrectomy patients remain unreported. Thus, the investigators propose this open-label randomized controlled trial to evaluate salt substitutes for postoperative renal protection in kidney tumor patients, establishing evidence-based dietary strategies for renal function preservation.
Therefore, the investigators plan to provide study participants with free salt substitute and standardized salt containers (5g) for one year. Participants will receive a one-month supply of free salt substitute upon hospital discharge. Adherence will be assessed at the one-month follow-up visit via 24-hour urine collection. Based on adherence confirmation, the next two-month supply of free salt substitute will be dispensed, continuing until the three-month follow-up.
This process will be repeated for subsequent phases: Adherence will be evaluated at discharge and each follow-up visit before dispensing the next phase's supply of free salt substitute.To enhance adherence during the extended interval between the 6-month and 12-month postoperative follow-ups: A telemedicine follow-up will be conducted at 9 months post-operation.Adherence will be assessed using a self-administered questionnaire, and the salt substitute will be remotely dispensed upon confirmation.
Non-adherence protocol:
First occurrence: Participants will receive intensive education reinforcing the importance of salt substitute use to improve adherence.
Recurrence: Participants will be discontinued from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salt substitute | Experimental | Participants will consume salt substitutes |
|
| Common salt | No Intervention | Participants will consume Common salt |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salt substitute | Dietary Supplement | Patient consume salt substitutes daily while strictly adhering to WHO-recommendedsalt intake levels for 1 year.Salt substitutes (potassium-enriched low-sodium salt, primarily NaCl and KCl) reduce sodium content versus regular salt |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated glomerular filtration rate (eGFR) | Estimated glomerular filtration rate (eGFR) in kidney tumor patients at 12 months after surgery | Postoperative 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Annual eGFR decline rate | Annual decline rate of eGFR at 12 months postoperatively compared to the "new baseline" post-surgery | Postoperative 12 months |
| eGFR decline | Proportion of patients with rapid eGFR decline (>3 ml/min/1.73m²/year) in each group |
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Inclusion Criteria:
Participants must meet all of the following criteria:
Exclusion Criteria:
Participants will be excluded if they meet any of the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qu Le M.D | Contact | +86 15720625951 | septsoul@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Postoperative 12 months |
| Reduction from baseline | Decline in eGFR at 12 months postoperatively from the new postoperative baseline (ml/min/1.73m²) | Postoperative 12 months |
| Incidence of adverse events | Incidence rate of hyperkalemia (serum potassium ≥5.5 mmol/L) and other adverse events | Postoperative 12 months |
| Incidence of CKD progression | The 1-year incidence of CKD progression, which was defined as a worse CKD stage compared to baseline. | Postoperative 12 months |
| Progression of proteinuria | Progression of proteinuria (defined as ≥30% increase in urine albumin-to-creatinine ratio from baseline) | Postoperative 12 months |
| Quality of life questionnaire score | Kidney Disease Quality of Life 36-Item Short Form Survey;The scoring ranges from 0 to 100, with higher scores indicating better quality of life in patients. | Postoperative 12 months |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |