Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia

What Was Tested

The trial (phase 3) is built around Desmopressin.

ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.

It had two arms (groups): DDAVP (experimental) and Standard hyponatremia treatment (active comparator).

The registry classes the interventions as drug.

More on the Plan

However, all investigators will be unaware of aggregate outcomes during the study and brain MRI imaging will be performed and analyzed blinded to the randomization group.

Who Took Part

The registry lists 260 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults ( ≥18 years). Current admission in ICU.

The full record lists 4 inclusion and 22 exclusion criteria; among the exclusions: severe acute kidney injury (kdigo 3); coronary patients well stabilized with trinitrine-based medicines; recent neurosurgery or traumatic brain injury.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Desmopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Desmopressin group and the comparison group ran side by side rather than switching.

Everyone knew when Desmopressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-12-17 with completion listed for 2026-09-30.

It ran at 12 sites in France (12).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 24 secondary outcomes, for example the reversal of acute neurological symptoms in patients with neurological symptoms at inclusion, ICU and hospital length of stay, survival, the occurrence of central pontine myelinolysis diagnosed on clinical and MRI criteria, the occurrence of any (pontine or extrapontine) osmotic demyelination as assessed by brain MRI and the urine output between H0 and H6.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Desmopressin in 260 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.