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

ConditionHyponatremia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ( ≥18 years)

Current admission in ICU

Severe hyponatremia defined by SNa <120 mmol/L in the presence of neurological symptoms (seizures, stupor defined as Glasgow score < 12, or signs of brain herniation) or by SNa <115 mmol/L

Normal or decreased extracellular fluid volume

Disqualifiers

Obvious increase of extracellular fluid volume (cirrhosis with ascites, congestive heart failure, nephrotic syndrome);

Hyponatremia caused by hyperglycaemia (> 30 mmol/L) or hypertriglyceridemia (10 g/L) or hyperproteinaemia (120 g/L)

Severe acute kidney injury (KDIGO 3)

Severe chronic kidney disease (eGFR <20 ml/min)

Trial design

Design model

Parallel

Treatments tested in this trial

  • DDAVP

    Drug

    Posology: 4µg in 2ml IV solution Route of administration: Intravenous Duration of treatment: 48h maximum (additional doses every 6h)

  • Standard hyponatremia treatment

    Drug

    Standard hyponatremia treatment alone : Presence of neurological symptoms : sodium chloride 3% 150ml for 20 min Absence of neurological symptoms : Hyper or isotonic fluid but never hypotonic

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: DDAVPExperimental treatment 1 intervention
Group B: Standard hyponatremia treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

reduced occurrence of overcorrection of serum sodium concentration (SNa) in the first 48 hours after randomization

proportion of patients with SNa level overcorrection : any risk factor: SNa increase \> 6 mmol/L in less than H24, or \>12 mmol/L in less than H48. Without risk factor: SNa increase \> 10 mmol/L in less than H24, or \> 18 mmol/L in less than H48

Time frame
48 hours after the randomization

Secondary outcomes

1

the reversal of acute neurological symptoms in patients with neurological symptoms at inclusion

proportion of patients with neurological symptoms at inclusion and who subsequently have a normal Glasgow Coma Scale at H6

Time frame
6 hours after the randomization
2

ICU and hospital length of stay

length of ICU and hospital stay

Time frame
ICU or hospital discharge
3

survival

time to death after inclusion

Time frame
death after randomization
4

the occurrence of central pontine myelinolysis diagnosed on clinical and MRI criteria

proportion of patients with the occurrence of central pontine myelinolysis diagnosed on clinical and MRI criteria at day 15 (or earlier if clinically justified)

Time frame
15 days after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov
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