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The Efficiency of Furosemide, Salt tablet and Fluid restriction for Long-term Treatment of Patients with Syndrome of Inappropriate Antidiuresis (SIAD): A Double-blinded Randomized Controlled Trial

The Efficiency of Furosemide, Salt tablet and Fluid restriction for Long-term Treatment of Patients with Syndrome of Inappropriate Antidiuresis (SIAD): A Double-blinded Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20170629004
Enrollment
90
Registered
2017-06-29
Start date
2017-05-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia in Syndrome of inappropriate antidiuresis Hyponatremia Treatment Furosemide Fluid restriction Salt tablet

Interventions

Restrict oral fluid intake per day depending on ratios of urine sodium plus urine potassium divided by serum sodium,Fluid restriction as arm 1 plus furosemide 20&#45
40 mg/day,Fluid restriction as arm 1 plus furosemide 20&#45
40 mg/day plus salt tablet 3 grams/day
Placebo Comparator Behavioral,Active Comparator Drug,Active Comparator Drug
Fluid restriction alone ,fluid restriction plus furosemide,fluid restriction plus furosemide plus salt tablet

Sponsors

Renal Division, Department of Internal Medicine, Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age of more than 18 years old - Serum sodium ≤130 mmol/L - Chronic hyponatremia (>48 hour after onset or unknown onset) - Diagnosis of SIAD, all following criterion must be met: - Effective serum osmolality100 mOsm/kg H2O - Clinical euvolemia - Urine sodium concentration >30 mmol/L with normal dietary salt and water intake - Absence of hypothyroidism (thyroid-stimulating hormone 1.2 or diagnosed as acute kidney injury)

Exclusion criteria

Exclusion criteria: - Clinical overt hypovolemia or hypervolemia - Decompensated liver cirrhosis, symptomatic heart failure, and nephrotic syndrome - Hemodynamic unstable - Current using investigational agents (salt tablet or furosemide), other diuretics and steroids - Severe symptomatic hyponatremia at diagnosis (defined as vomiting, cardiorespiratory distress, abnormal and deep somnolence, seizures, and coma (which define as Glasgow Coma Scale 8) - Hyperglycemia enough to interfere with assessment of serum sodium, defined as random plasma glucose >300 mg/dL at the time of diagnosis - Receiving renal replacement therapy - Post kidney transplant status - Furosemide allergy - Contraindicated for eating or feeding via enteral route

Design outcomes

Primary

MeasureTime frame
Serum sodium concentration Day 4 and day 28 after randomization Ion selective electrode system (Cobas 6000 & Cobas 8000, Roche, USA)

Secondary

MeasureTime frame
Percentage of patients with normal serum sodium concentration Day 4 and day 28 after randomization Number of patients with normal serum sodium concentration divided by total number of patients in th ,Adverse effects of furosemide, salt tablet and fluid restriction Day 0-28 after randomization Observations of adverse effects

Countries

Thailand

Contacts

Public ContactKajohnsak Noppakun

Chiang Mai University

kajohnsak.noppakun@cmu.ac.th66-81-595-3465

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026