University Hospital Basel
Basel, 4031, Switzerland
Completed
NCT Number: NCT02874807
Effects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH - the SAND Study
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–84 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Hyponatremia <130mmol/l due to SIADH
Exclusion criteria
- 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
Treatment and study plan
Empagliflozin
DrugPlacebo
OtherPrimary outcomes
-
Serum sodium
Time frame: 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 outcomes
-
Serum sodium
Time frame: 1 day
Serum sodium concentration 1 day after start of Treatment with study drug
-
Serum sodium
Time frame: 2 days
Serum sodium concentration 2 days after start of treatment with study drug
-
Serum sodium
Time frame: between day 1 to day 30
Serum sodium concentration at discharge from hospital
-
Serum sodium
Time frame: 30 days
Serum sodium concentration 30 days after start of treatment with study drug
-
Fluid intake
Time frame: 4 days
amount of daily fluid intake
-
Urinary excretion
Time frame: 4 days
amount of daily urinary excretion
-
Serum electrolytes
Time frame: 4 days
change of serum electrolytes from baseline to day 5
-
Urinary electrolytes
Time frame: 4 days
Change of Serum electrolytes from baseline to day 5
-
Serum osmolality
Time frame: 4 days
Change of Serum osmolality from baseline to day 5
-
Urine osmolality
Time frame: 4 days
Change of urinary osmolality from baseline to day 5
-
Serum glucose
Time frame: 4 days
Change of Serum glucose from baseline to day 5
-
Urinary glucose
Time frame: 4 days
Change of urinary Glucose from baseline to day 5
-
Copeptin
Time frame: 4 days
Change of Copeptin from baseline to day 5
-
Aldosterone
Time frame: 4 days
Change of Aldosterone from baseline to day 5
-
Renin
Time frame: 4 days
Change of Renin from baseline to day 5
-
atrial natriuretic peptide (ANP)
Time frame: 4 days
Change of ANP from baseline to day 5
-
Brain-Natriuretic-Peptide (BNP)
Time frame: 4 days
Change of BNP from baseline to day 5
-
General well-being
Time frame: 4 days
course of General well-being from baseline to day 5 as assessed by patient's self-rating score
-
General well-being
Time frame: 30 days
course of General well-being from baseline to day 30 as assessed by patient's self-rating score
-
Symptoms of hyponatremia
Time frame: 4 days
course of hyponatremia symptoms from baseline to day 5
-
Symptoms of hyponatremia
Time frame: 30 days
Course of hyponatremia symptoms from baseline to day 30
-
Body weight
Time frame: 4 days
Change of Body weight from baseline to day 5
-
Blood pressure
Time frame: 4 days
Change of blood pressure from baseline to day 5
-
Heart rate
Time frame: 4 days
Change of heart rate from baseline to day 5
-
length of hospital stay
Time frame: 30 days
length of hospital stay
-
Treatment escalation
Time frame: 30 days
rate of Need for Treatment escalation
-
ICU Admission rate
Time frame: 30 days
rate of Admission to ICU
-
Recurrence hyponatremia
Time frame: 30 days
recurrence rate hyponatremia
-
Hospital readmission rate
Time frame: 30 days
rate of readmission
Sponsors and collaborators
Lead sponsor
University Hospital, Basel, Switzerland
Other
Registry information
Acronym: SAND
Important dates
- Study start
- 2016
- Primary completion
- 2018
- Study completion
- 2019
- First posted
- Aug 22, 2016
- Registry last updated
- Jun 13, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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