Fluid restriction versus no active treatment in chronic SIAD

• Register: ISRCTN
• Last refreshed on: 17 August 2021
• Main ID: ISRCTN34822127
• Date of registration: 27/04/2018
• Prospective Registration: Yes
• Primary sponsor: Beaumont Hospital
• Public title: Fluid restriction versus no active treatment in chronic SIAD
• Scientific title: 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.
• Date of first enrolment: 01/05/2018
• Target sample size: 56
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN34822127
• Study type: Interventional
• Study design: Prospective unblinded randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Ireland

Contacts

• Name: Chris Thompson

Key inclusion & exclusion 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:
1. Symptomatic hyponatraemia
2. Plasma sodium < 120 mmol/L
3. An underlying cause for hyponatraemia is recognised which is temporary or rapidly reversible with treatment of the underlying condition or removal of the causative medication
4. Hypo- or hyper-volemia
5. Diuretic therapy
6. Uncontrolled hyperglycaemia (blood glucose > 16.6 mmol/L)
7. Pregnancy


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 blocks of four.
Participants randomised to fluid restriction are instructed to limit total fluid intake to 1 litre per 24 hours. Those randomised to no active treatment should continue to drink as usual. Fluid intake is self-reported. The intervention period is 30 days. Participants are assessed at day 1, 4, 11, 18 and 30, including medication check, documenting fluid intake records and blood sampling.

Primary Outcome(s)

Plasma sodium is measured from a blood sample at baseline, 4 days and 30 days

Secondary Outcome(s)

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.

Source(s) of Monetary Support

Beaumont Hospital Endocrinology Research Fund

Ethics review

Status:
Approval date:
Contact:

Beaumont Hospital Research Ethics Committee, 26/03/2018, ref: REC REF 18/04

Results

• Date Completed: 31/01/2020