Kidney-protective Intervention With Salt Substitute After Kidney Tumor Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJinling Hospital, China
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
Participant or cohabiting family members currently using potassium-sparing diuretics or potassium supplements, or prior use of salt substitutes;
Post-discharge eGFR <45 ml/min/1.73m² without significant fluctuation;
Comorbid chronic kidney diseases (e.g., diabetic nephropathy, lupus nephritis);
Preoperative history of urinary tract obstruction;
Trial design
Design model
Parallel
Treatments tested in this trial
Salt substitute
Dietary supplementPatient 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
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Salt substituteExperimental treatment 1 intervention
Group B: Common saltNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Estimated glomerular filtration rate (eGFR)
Estimated glomerular filtration rate (eGFR) in kidney tumor patients at 12 months after surgery
Time frame
Postoperative 12 monthsSecondary outcomes
1
Annual eGFR decline rate
Annual decline rate of eGFR at 12 months postoperatively compared to the "new baseline" post-surgery
Time frame
Postoperative 12 months2
eGFR decline
Proportion of patients with rapid eGFR decline (\>3 ml/min/1.73m²/year) in each group
Time frame
Postoperative 12 months3
Reduction from baseline
Decline in eGFR at 12 months postoperatively from the new postoperative baseline (ml/min/1.73m²)
Time frame
Postoperative 12 months4
Incidence of adverse events
Incidence rate of hyperkalemia (serum potassium ≥5.5 mmol/L) and other adverse events
Time frame
Postoperative 12 monthsSponsors and contacts
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Source ClinicalTrials.gov