Effects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH - the SAND Study
- Registration Number
- NCT02874807
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- Hyponatremia <130mmol/l due to SIADH
- any Treatment for SIADH during >48h before study start
- severe illness with ICU-Admission
- Treatment with 3% sodium Chloride (NaCl) solution
- uncontrolled hypothyroidism
- uncontrolled adrenal insufficiency
- severe renal impairment (GFR <30ml/min), end stage renal disease
- severe hepatic impairment (Child-Pugh class C)
- systolic blood pressure <90mmHg
- Diabetes mellitus type 1
- acute myocardial infarction or chronic venous insufficiency (CVI)
- Treatment with SGLT2 Inhibitor, Lithium Chloride or Urea
- recurrent urinary-/genital tract infections
- contraindication for lowering blood pressure
- severe immunosuppression
- pregnancy or breastfeeding
- palliative care
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Treatment with Placebo once daily for four days Empagliflozin Empagliflozin Treatment with empagliflozin 25mg once daily for four days
- Primary Outcome Measures
Name Time Method Serum sodium 4 days 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
- Secondary Outcome Measures
Name Time Method Serum glucose 4 days Change of Serum glucose from baseline to day 5
Blood pressure 4 days Change of blood pressure from baseline to day 5
Urinary excretion 4 days amount of daily urinary excretion
Serum electrolytes 4 days change of serum electrolytes from baseline to day 5
Urinary electrolytes 4 days Change of Serum electrolytes from baseline to day 5
Copeptin 4 days Change of Copeptin from baseline to day 5
Body weight 4 days Change of Body weight from baseline to day 5
Treatment escalation 30 days rate of Need for Treatment escalation
Hospital readmission rate 30 days rate of readmission
General well-being 30 days course of General well-being from baseline to day 30 as assessed by patient's self-rating score
Fluid intake 4 days amount of daily fluid intake
Serum osmolality 4 days Change of Serum osmolality from baseline to day 5
Renin 4 days Change of Renin from baseline to day 5
ICU Admission rate 30 days rate of Admission to ICU
Serum sodium 30 days Serum sodium concentration 30 days after start of treatment with study drug
Urine osmolality 4 days Change of urinary osmolality from baseline to day 5
Urinary glucose 4 days Change of urinary Glucose from baseline to day 5
atrial natriuretic peptide (ANP) 4 days Change of ANP from baseline to day 5
Aldosterone 4 days Change of Aldosterone from baseline to day 5
Brain-Natriuretic-Peptide (BNP) 4 days Change of BNP from baseline to day 5
Heart rate 4 days Change of heart rate from baseline to day 5
length of hospital stay 30 days length of hospital stay
Symptoms of hyponatremia 30 days Course of hyponatremia symptoms from baseline to day 30
Recurrence hyponatremia 30 days recurrence rate hyponatremia
Trial Locations
- Locations (1)
University Hospital Basel
🇨🇭Basel, Switzerland