Tolvaptan versus fluid restriction in acutely hospitalised patients with low blood sodium concentration.

Phase 3

Completed

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

• Registration Number: ACTRN12619001683123
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-02
• Study Completion: 2024-05-12
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Acutely hospitalised patients with hypotonic hyponatraemia (serum sodium 115-130 mmol/L) at 0800 hours on day 1 of their hospital admission (day of presentation being day 0).

Exclusion Criteria

Hypovolaemia
Acute polydipsia (urine specific gravity < 1.003)
Severe symptoms warranting hypertonic saline (vomiting, coma (GCS <8), deep somnolence (sedation score >1), seizure, respiratory arrest)
Thiazide or thiazide-like diuretic use within preceding 5 days
Risk factors for osmotic demyelination syndrome (malnutrition, alcohol abuse, Child-Pugh B or C cirrhosis, potassium < 3.5 mmol/L on day 1, increment in serum sodium from day 0 to day 1 of > 0.5mmol/L/h or > 10 mmol/L).
Systolic blood pressure <100mmHg
Glucocorticoid deficiency
Mineralocorticoid deficiency
Overt hypothyroidism
Chronic kidney disease stage 5
Inability to drink fluid unaided
Pregnancy or breastfeeding
Marked hyperglycaemia (Day 1 venous blood gas glucose > 20 mmol/L)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in average serum sodium from baseline (day 1 of admission) to day 4 (or day of hospital discharge if that occurs earlier than day 4).[ Day 4 of admission or day of hospital discharge if earlier than day 4.]