Syndrome of inappropriate antidiuresis (SIADH) is characterized by an imbalance of antidiuretic vasopressin (AVP) secretion. The impaired AVP regulation leads to water retention and secondary natriuresis and is a common cause for hyponatremia. The therapeutic options, aside from treating the underlying disease, depend upon the onset and severity of the symptoms and involve usually fluid restriction or hypertonic saline infusion. Alternative therapeutic options are loop diuretics, administration of oral urea or vasopressin receptor antagonists (vaptans). Despite those options, there are a considerable number of patients which do not sufficiently respond, making additional therapy necessary. Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is a new treatment option developed for patients with diabetes mellitus type 2. The SGLT2 is expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered glucose. The inhibition of SGLT2 results in renal excretion of glucose with subsequent osmotic diuresis. This mechanism could result in a therapeutic effect in patients with hypotonic hyponatremia as in SIADH. The aim of this study is to evaluate whether empagliflozin (Jardiance)® has an effect on the serum sodium levels of patients with SIADH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
University Hospital Basel
Basel, Switzerland
Serum sodium
The primary outcome is the change in serum sodium concentration from baseline to day 5, i.e. 4 days after start of treatment with study drug
Time frame: 4 days
Serum sodium
Serum sodium concentration 1 day after start of Treatment with study drug
Time frame: 1 day
Serum sodium
Serum sodium concentration 2 days after start of treatment with study drug
Time frame: 2 days
Serum sodium
Serum sodium concentration at discharge from hospital
Time frame: between day 1 to day 30
Serum sodium
Serum sodium concentration 30 days after start of treatment with study drug
Time frame: 30 days
Fluid intake
amount of daily fluid intake
Time frame: 4 days
Urinary excretion
amount of daily urinary excretion
Time frame: 4 days
Serum electrolytes
change of serum electrolytes from baseline to day 5
Time frame: 4 days
Urinary electrolytes
Change of Serum electrolytes from baseline to day 5
Time frame: 4 days
Serum osmolality
Change of Serum osmolality from baseline to day 5
Time frame: 4 days
Urine osmolality
Change of urinary osmolality from baseline to day 5
Time frame: 4 days
Serum glucose
Change of Serum glucose from baseline to day 5
Time frame: 4 days
Urinary glucose
Change of urinary Glucose from baseline to day 5
Time frame: 4 days
Copeptin
Change of Copeptin from baseline to day 5
Time frame: 4 days
Aldosterone
Change of Aldosterone from baseline to day 5
Time frame: 4 days
Renin
Change of Renin from baseline to day 5
Time frame: 4 days
atrial natriuretic peptide (ANP)
Change of ANP from baseline to day 5
Time frame: 4 days
Brain-Natriuretic-Peptide (BNP)
Change of BNP from baseline to day 5
Time frame: 4 days
General well-being
course of General well-being from baseline to day 5 as assessed by patient's self-rating score
Time frame: 4 days
General well-being
course of General well-being from baseline to day 30 as assessed by patient's self-rating score
Time frame: 30 days
Symptoms of hyponatremia
course of hyponatremia symptoms from baseline to day 5
Time frame: 4 days
Symptoms of hyponatremia
Course of hyponatremia symptoms from baseline to day 30
Time frame: 30 days
Body weight
Change of Body weight from baseline to day 5
Time frame: 4 days
Blood pressure
Change of blood pressure from baseline to day 5
Time frame: 4 days
Heart rate
Change of heart rate from baseline to day 5
Time frame: 4 days
length of hospital stay
length of hospital stay
Time frame: 30 days
Treatment escalation
rate of Need for Treatment escalation
Time frame: 30 days
ICU Admission rate
rate of Admission to ICU
Time frame: 30 days
Recurrence hyponatremia
recurrence rate hyponatremia
Time frame: 30 days
Hospital readmission rate
rate of readmission
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.