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Assessment of Quantity and Utility of water for ICU-Acquired hypernatraemia. A Pilot, Six-Centre, Open-Label, Safety and Physiological Efficacy Randomised Controlled Trial

Assessment of Quantity and Utility of water for ICU-Acquired hypernatraemia. A Pilot, Six-Centre, Open-Label, Safety and Physiological Efficacy Randomised Controlled Trial in ICU patients.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000904471
Acronym
AQUA Trial
Enrollment
6
Registered
2025-08-20
Start date
2025-12-29
Completion date
2026-12-31
Last updated
2026-04-27

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

Conditions

None listed

Brief summary

The AQUA Pilot Trial is testing whether giving hypotonic fluids (such as 5% glucose or enteral free water) helps critically ill patients with ICU-acquired hypernatraemia (high sodium levels) recover faster compared to usual care. Patients will be randomly assigned to receive either a structured hypotonic fluid protocol or standard treatment to determine which approach leads to quicker sodium normalisation. The study hypothesis is that the protocolised administration of hypotonic fluid will result in a shorter time to normal serum sodium levels (equal or less than 145 mmol/L) compared to usual care. This research aims to help doctors develop better treatment strategies for managing hypernatraemia in intensive care patients, potentially improving outcomes and reducing complications. The trial will also assess safety by monitoring glucose levels, electrolyte balance, and other important clinical measures.

Interventions

Patients will be randomised to receive protocolised administration of hypotonic fluid or usual care for 7 days or ICU discharge. - Protocolised hypotonic fluid will be commenced at 100 mL/h, and repeat sodium as measured by blood gas machine will be performed at 6 hours. - Hypotonic fluid can be administered as enteral free water, intravenous 5% glucose, or a combination to achieve the desired rate. - The choice of hypotonic fluid will be at the discretion of the treating clinician. - All pat

Patients will be randomised to receive protocolised administration of hypotonic fluid or usual care for 7 days or ICU discharge. - Protocolised hypotonic fluid will be commenced at 100 mL/h, and repeat sodium as measured by blood gas machine will be performed at 6 hours. - Hypotonic fluid can be administered as enteral free water, intravenous 5% glucose, or a combination to achieve the desired rate. - The choice of hypotonic fluid will be at the discretion of the treating clinician. - All patients will also receive 6-hourly sodium measurements for the first 24 hours. - If sodium is less than 142 mmol/L, the hypotonic fluid will cease. - If sodium is greater than or equal to 142 mmol/L AND less than the previous sodium, the hypotonic fluid will continue at the current rate. - If sodium exceeds the previous sodium, the rate of hypotonic fluid will be increased by 100mL/h. - The intervention protocol will be conducted for 7 days, after which all patients receive usual care. There is no protocolised maximum hypotonic fluid rate. Adherence to the protocol will be assessed by review of the medical records. The intervention will be stopped if the patient is started on renal replacement therapy, if the patient is discharged from ICU, if the treating clinician has concerns about cerebral oedema, or, of course, in case of death.

Sponsors

Anaesthesia and Intensive Care SPF of Austin Health
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Adult aged 18 years or older • Admitted to the intensive care unit • ICU-acquired hypernatraemia, defined as serum sodium greater than 145 mmol/L • Receiving mechanical ventilation

Exclusion criteria

• Serum sodium greater than 145 mmol/L on admission to ICU; or • Fulfilled eligibility criteria greater than 12 hours ago; or • Currently receiving 5% glucose intravenous infusion at rate greater than 50 mL/h; or • Currently receiving renal replacement therapy, or planned to start RRT in the next 12 hours; or • Pulmonary oedema with PaO2 / FiO2 < 100; or • Diabetic ketoacidosis or • Hyperosmolar hyperglycaemia state; or • Pregnancy of breastfeeding; or • Death is deemed inevitable as a result of the current acute illness, and either the treating clinician, the patient or the substitute decision-maker is not committed to full active treatment; or • Considered to be at high risk of cerebral oedema by the treating clinician (e.g. traumatic brain injury or acute brain disease); or • Clinician believes that being enrolled in intervention or control arm is not in the best interest of the patient; or • Known Diabetes Insipidus • Previous enrolment in this study

Outcome results

None listed

Source: ANZCTR · Data processed: May 1, 2026