Fluid restriction versus 0.9% saline infusion in the treatment of hyponatraemia due to the syndrome of inappropriate antidiuresis in patients with pneumonia

• Register: ISRCTN
• Last refreshed on: 13 July 2020
• Main ID: ISRCTN89527210
• Date of registration: 29/01/2018
• Prospective Registration: Yes
• Primary sponsor: Beaumont Hospital
• Public title: Fluid restriction versus 0.9% saline infusion in the treatment of hyponatraemia due to the syndrome of inappropriate antidiuresis in patients with pneumonia
• Scientific title: A prospective randomised comparison of the effects of fluid restriction versus 0.9% saline infusion on plasma sodium and blood pressure in patients with pneumonia complicated by SIAD (syndrome of inappropriate antidiuresis)
• Date of first enrolment: 01/02/2018
• Target sample size: 40
• Recruitment status: Ongoing
• URL: http://isrctn.com/ISRCTN89527210
• 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. Eu-volemic
3. New asymptomatic hyponatraemia with plasma sodium 120 - 130 mmol/L
4. Biochemical confirmation of SIAD, including exclusion of adrenal insufficiency and hypothyroidism.
5. Radiographic confirmation of pneumonia
6. Clinical confirmation of pneumonia
7. Systolic blood pressure > 100 mmHg

Exclusion criteria:
1. Symptomatic or severe hyponatraemia (plasma sodium < 120 mmol/L)
2. Volume depletion / hypovolaemia / systolic BP < 100 mmHg
3. CCF
4. Uncontrolled hyperglycemia
5. AKI
6. Diuretic therapy
7. Clinical imperative for intravenous fluids
8. Chronic hyponatraemia


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Syndrome of inappropriate antidiuresis secondary to pneumonia
Respiratory
Syndrome of inappropriate antidiuresis secondary to pneumonia

Intervention(s)

Once informed consent has been acquired, participants are randomised to either fluid restriction or 0.9% saline infusion using a computer generated randomisation table using random permutated blocks of four. Patients randomised to fluid restriction are instructed to limit total fluid intake to 1 liter per 24 hours. This includes intravenous medications and oral intake. Those randomised to 0.9% saline infusion receive 2 liters of intravenous 0.9% saline over 24 hours, and no restrictions on oral intake will be recommended. The intervention period lasts for 72 hours. In total there are four assessments (day 1, 2, 3, 4).

Primary Outcome(s)

1. Change in plasma sodium from baseline to day 4 (plasma sodium is measured using ion-selective electrode)
2. Change in blood pressure from baseline to day 4 (blood pressure is measured using amubulatory blood pressure monitoring on day 1 and day 3, and using office BP monitoring daily)

Secondary Outcome(s)

1. Proportion of patients achieving eunatraemia daily
2. Length of hospital stay, measured using the hospital database, up until time of discharge
3. Patient reported outcome (well-being), measured using the SF-12 and EQ-5D questionnaires, at baseline and day 4

Source(s) of Monetary Support

Beaumont Hospital Endocrinology Research Fund

Ethics review

Status:
Approval date:
Contact:

Beaumont Hospital Research Ethics Committee, 10/11/2017, ref: REC REF 17/79

Results

• Results available: Yes
• Date Completed: 01/10/2020