Fluid restriction versus no active treatment in chronic SIAD

A prospective randomised controlled trial comparing the effects of fluid restriction with no active hyponatremia treatment on rate of change of plasma sodium, and markers of hyponatraemia related morbidity, in patients with chronic hyponatremia due to the syndrome of inappropriate antidiuresis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN34822127

Enrollment

Registered

2018-04-27

Start date

2018-05-01

Completion date

Unknown

Last updated

2021-08-17

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

Conditions

Chronic asymptomatic syndrome of inappropriate antidiuresis (SIAD) Nutritional, Metabolic, Endocrine Syndrome of inappropriate antidiuresis (SIAD)

Interventions

Once informed consent is acquired, participants are randomised to either fluid restriction or no active hyponatraemia treatment using a computer generated randomisation schedule using permutated block

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age > 18 years 2. Chronic hyponatraemia with plasma sodium 120 - 130 mmol/L 3. Euvolemia and biochemical confirmation of SIAD.

Exclusion criteria

Exclusion criteria: 1. Symptomatic hyponatraemia 2. Plasma sodium 16.6 mmol/L) 7. Pregnancy

Design outcomes

Primary

Measure	Time frame
Plasma sodium is measured from a blood sample at baseline, 4 days and 30 days	—

Secondary

Measure	Time frame
1. Percentage of patients achieving a rise in plasma sodium > 5 mmol/L is assessed from a blood sample at days 4 and 30. 2. Percentage of patients achieving a plasma sodium > 130 mmol/L is assessed from a blood sample at days 4 and 30. 3. Length of hospital stay (if applicable) is assessed using the hospital record system at day 30. 4. Plasma sodium at time of hospital discharge (if applicable) is assessed using the hospital laboratory record system. 5. Urinary sodium, potassium and osmolality in those with treatment failure versus those who achieve above treatment thresholds is assessed from urine sample taken at baseline. 6. Mental and physical well-being is assessed using SF12 questionnaire at baseline and after 1 month. 7. Balance is assessed using the FootScan analysis mat at baseline and after 1 month.	—

Measure

Time frame

1. Percentage of patients achieving a rise in plasma sodium > 5 mmol/L is assessed from a blood sample at days 4 and 30. 2. Percentage of patients achieving a plasma sodium > 130 mmol/L is assessed from a blood sample at days 4 and 30. 3. Length of hospital stay (if applicable) is assessed using the hospital record system at day 30. 4. Plasma sodium at time of hospital discharge (if applicable) is assessed using the hospital laboratory record system. 5. Urinary sodium, potassium and osmolality in those with treatment failure versus those who achieve above treatment thresholds is assessed from urine sample taken at baseline. 6. Mental and physical well-being is assessed using SF12 questionnaire at baseline and after 1 month. 7. Balance is assessed using the FootScan analysis mat at baseline and after 1 month.

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Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026