Tolvaptan versus Urea in acutely hospitalised patients with low blood sodium concentratio

Phase 3

• Conditions: Hyponatraemia; Metabolic and Endocrine - Other endocrine disorders

• Registration Number: ACTRN12624000756527
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-20
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Acutely hospitalised patients with hypotonic hyponatraemia (serum sodium 115-130 mmol/L) with sodium rise less than or equal to 4 mmol/L per 24 hours at 0800 hours on day 1 of their hospital admission (day of presentation being day 0), despite at least 24 hours of fluid restriction.

Exclusion Criteria

- Hypovolaemia defined as either clinical impression of hypovolaemia; or urine sodium <20 mmol/L
Acute polydipsia defined by first collected urine sample specific gravity <1.003
- Severe symptoms warranting hypertonic saline: repeated vomiting on Day 1 of admission, coma (defined by Glasgow Coma Score <8) on Day 1 of admission, deep somnolence (defined by sedation score>1) on Day 1 of admission, seizure at any time during admission, respiratory arrest at any time during admission
- Thiazide or thiazide-like diuretic use within the preceding 5 days
- Risk factors for osmotic demyelination syndrome: malnutrition (BMI <16 or other clinical concern), alcohol abuse (>14 standard drinks per week), child-Pugh B or C cirrhosis, hypokalaemia (K<3.0 mmol/L on Day 1 of admission), increment in serum sodium from baseline to Day 1 of >5mmol/L
- Other endocrine causes of hyponatraemia: untreated glucocorticoid deficiency or mineralocorticoid deficiency, overt hypothyroidism (thyroid stimulating hormone >20)
- Chronic Kidney Disease Stage 5
- Systolic blood pressure <100mmHg
- Inability to drink fluid orally unaided
- Pregnancy (by history, confirmed if necessary by serum beta-hCG) or breastfeeding
- Extreme hyperglycaemia (Day 1 venous blood gas glucose >20mmol/L)

Study & Design

• Study Type: Interventional
• Study Design: Not specified