Effect of the SGLT2 inhibitor empagliflozin in patients with euvolemic and hypervolemic hyponatremia – a multicentric randomized double-blind placebo-controlled trial (the EMPOWER Study)

简要总结

主要结局

次要结局

• Short (day 1, day 2, day 3, day of discharge term course of plasma sodium level
• Urine sodium, eGFR, serum and urine -osmolality, -potassium, -creatinine, -urea, -uric acid, -glucose, -CRP at baseline, on day 4, and day 30
• Blood and urine aliquots on day 0, day 1, day 4 and day 30, including predefined analysis: markers of salt-water balance (MR-proANP, NT-proBNP, copeptin, aldosteron, renin) and markers of bone metabolism (procollagen type I N propeptide (P1NP) and serum C telopeptide (CTX)
• Daily fluid intake (mL) from baseline (day 0) to day 4
• Change in body weight (including AUC 24h – 4 days), blood pressure and heart rate twice a day at baseline (day 0) and on day 1 and then once a day on day 2, day 3, day 4, and day 30
• Course of thirst and symptoms of hyponatremia assessed on a yes or no basis: headache, vertigo and nausea at baseline (day 0), on day 4 and day 30
• Course of general well-being rated by patients on a visual analogue scale (VAS) reaching from 0 (no well-being) to 10 (excellent well-being) at baseline (day 0), on day 4 and day 30
• Change in quality of life assessed by the EQ-5D-5L questionnaire at baseline (day 0), on day 4 and day 30
• Change in neurocognitive functions assessed by the MoCA Test and the Trail Making Test A and B at baseline (day 0), on day 4 and day 30
• Change in gait stability assessed by the Timed Up and Go Test at baseline (day 0), on day 4 and day 30
• Fall as admission (co)-diagnosis at baseline or as re-admission (co)-diagnosis during treatment period (Day 0 – Day 30)
• Incidence of fractures during the twelve months prior to treatment start, fractures as admission (co)-diagnosis at baseline or as re-admission (co)-diagnosis during treatment period (Day 0 – Day 30)
• Grip strength measured with a hand dynamometer at baseline (day0), on day 4 and day 30
• Percentage of patients with plasma sodium concentration that has normalized after 4, on day of discharge) and after 30 days of treatment
• Duration (days) until normonatremia has been reached
• Recurrence-rate of hyponatremia during treatment period (Day 0 – Day 30)
• Recurrence of hyponatremia after treatment completion according to plasma sodium measurement at follow up (day 37 +21/- 3 days)
• Need for additional hyponatremia treatment and treatment escalation (e.g. administration of 3% NaCl infusion) during treatment period (Day 0 – Day 30)
• Rate of ICU-admissions during treatment period (Day 0 – Day 30)
• Length of hospital stay (days)
• Rate of readmission due to hyponatremia and other causes during treatment period (Day 0 – Day 30)
• Baseline characteristics including age, gender, medical history, medication, date of hospitalisation and admission diagnosis.