Preventing Rapid Sodium Increase in Severe Hyponatremia in ICU Patients Using DDAVP A Multicenter Open-Label Randomized Trial

What this Trial Is About

This research aims to evaluate the use of DDAVP desmopressin to prevent rapid overcorrection of serum sodium levels in ICU patients with severe hyponatremia. The trial is a multicenter, prospective, open-label randomized controlled study that includes patients with severe hyponatremia defined by specific sodium levels and neurological symptoms, with stratification based on risk factors for central pontine myelinolysis. The study focuses on patients with normal or low extracellular fluid volume and investigates whether adding DDAVP to standard treatment reduces the risk of sodium overcorrection. Participants are randomized to receive either standard hyponatremia treatment alone or standard treatment plus DDAVP 4 gml intravenously, with additional doses every 6 hours for up to 48 hours. Standard treatment varies based on neurological symptoms, involving either sodium chloride 3% infusion or hypertonicisotonic fluids excluding hypotonic fluids. Due to the clear clinical effects of DDAVP on urine output and osmolarity, the trial is open-label, but MRI scans will be evaluated blinded to treatment allocation. During the study, participants will be monitored closely with assessments including neurological symptom evaluation, urine output and osmolality measurements at multiple time points, and brain MRI scans to detect demyelination. The primary outcome is the reduction of serum sodium overcorrection within 48 hours after randomization. Secondary outcomes include neurological symptom reversal, length of ICU and hospital stay, survival, and occurrence of osmotic demyelination. The study duration for each participant covers the initial 48 hours, with follow-up assessments up to 28 days after randomization.

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