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RECRUITING

NCT07062952

Kidney-protective Intervention With Salt Substitute After Kidney Tumor Surgery

Sponsor: Jinling Hospital, China

View on ClinicalTrials.gov

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.

Official title: Kidney-protective Intervention With Salt Substitute After Kidney Tumor Surgery: a Single-center Randomized Controlled Study(KISS Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-04-24

Completion Date

2027-12-31

Last Updated

2025-12-15

Healthy Volunteers

Conditions

Kidney Tumors CKD Salt Substitute Nephrectomy eGFR

Interventions

DIETARY_SUPPLEMENT

Salt substitute

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

Inclusion Criteria: * Participants must meet all of the following criteria: 1. Voluntary participation with signed informed consent from both the primary participant and all cohabiting family members, with commitment to study procedures and follow-up; 2. Age ≥18 years at enrollment (when signing informed consent), any gender; 3. Diagnosed kidney tumor patients who underwent radical nephrectomy or partial nephrectomy (no restrictions on surgical approach); 4. Preoperative eGFR \>60 ml/min/1.73m² (calculated by CKD-EPI equation); 5. Serum potassium \<4.8 mmol/L; 6. Predominantly home-based dietary habits (\>90% meals prepared at home, assessed via self-report); 7. Normal contralateral renal function at screening; 8. Normal cardiopulmonary and hepatic function: Exclusion Criteria: * Participants will be excluded if they meet any of the following: 1. Participant or cohabiting family members currently using potassium-sparing diuretics or potassium supplements, or prior use of salt substitutes; 2. Post-discharge eGFR \<45 ml/min/1.73m² without significant fluctuation; 3. Comorbid chronic kidney diseases (e.g., diabetic nephropathy, lupus nephritis); 4. Preoperative history of urinary tract obstruction; 5. Cohabiting family member(s) with CKD (eGFR \<45 ml/min/1.73m²); 6. Planned postoperative nephrotoxic medications (e.g., anti-neoplastic agents, immunotherapy); 7. Uncontrolled diabetes (HbA1c ≥12%); 8. Uncontrolled hypertension (seated SBP ≥180 mmHg or DBP ≥110 mmHg), symptomatic hypotension (SBP \<90 mmHg), or clinically evident hypovolemia; 9. Preoperative proteinuria (≥1+ on dipstick); 10. Severe cardiovascular disease (NYHA Class III-IV), gastrointestinal obstruction, or hyperkalemia history; 11. BMI \<18.5 kg/m² or \>30 kg/m²; 12. Participation in another clinical trial ≤30 days before randomization or concurrently; 13. Communication barriers or anticipated non-adherence; 14. Structural/functional urological abnormalities (e.g., duplicated kidneys, polycystic kidneys, renal artery stenosis, stones, BPH) or indwelling catheters; 15. Prior radiotherapy/ablation/surgery on the contralateral kidney; 16. Life expectancy \<6 months (e.g., metastatic renal carcinoma).

Locations (1)

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing

Nanjing, Jiangsu, China