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

Phase 3

Completed

• Conditions: Furosemide; Hyponatremia in Syndrome of inappropriate antidiuresis; Hyponatremia; Treatment; Fluid restriction; Salt tablet

• Registration Number: TCTR20170629004
• Lead Sponsor: Renal Division, Department of Internal Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-29
• Study Completion: 2018-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

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 osmolality<275 mOsm/kg
- Urine osmolality >100 mOsm/kg H2O
- Clinical euvolemia
- Urine sodium concentration >30 mmol/L with normal dietary salt and water intake
- Absence of hypothyroidism (thyroid-stimulating hormone <10 mIU/mL), glucocorticoid deficiency (unstimulated or stimulated cortisol level 10 ug/dL or) and significant renal insufficiency (define as serum creatinine > 1.2 or diagnosed as acute kidney injury)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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