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Study on Using Desmopressin Acetate Trihydrate to Prevent Sodium Overcorrection in Patients with Severe Hyponatremia

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the condition known as severe hyponatremia, which occurs when there is a dangerously low level of sodium in the blood. This can lead to serious health issues, especially if the sodium level rises too quickly. The trial aims to explore the use of a medication called DDAVP (also known as desmopressin acetate trihydrate) to prevent the rapid increase of sodium levels in patients with severe hyponatremia. The study will also involve the use of other substances like sodium chloride, potassium chloride, and glucose solutions, which are commonly used in medical treatments to manage fluid and electrolyte balance in the body.

The purpose of this study is to determine if using DDAVP can help control the sodium levels in the blood more effectively during the first 48 hours of treatment. This is important because a rapid increase in sodium can lead to complications such as brain damage. The study will be conducted in a hospital setting, where participants will receive either DDAVP or a placebo, along with other standard treatments. The trial will monitor the sodium levels and other health indicators to assess the effectiveness of the treatment.

Participants in the study will be closely observed for any changes in their condition, including the presence of neurological symptoms like seizures or confusion. The study will also track the length of hospital stay and any potential side effects. By the end of the study, researchers hope to gather valuable information on how to better manage severe hyponatremia and improve patient outcomes. This research could lead to more effective treatment strategies for those at risk of rapid sodium level changes.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is admitted to the intensive care unit (ICU) with a diagnosis of severe hyponatremia. This condition is characterized by low levels of sodium in the blood, which can lead to neurological symptoms such as seizures or stupor.

  2. Step 2

    Initial assessment

    The patient's sodium levels are measured to confirm the severity of hyponatremia. The presence of neurological symptoms is also assessed. This step helps determine the appropriate treatment plan.

  3. Step 3

    Randomization and treatment initiation

    The patient is randomly assigned to receive either the standard treatment or the treatment with DDAVP (desmopressin acetate trihydrate). This medication is administered intravenously to help control the correction of sodium levels in the blood.

  4. Step 4

    Monitoring sodium levels

    The patient's sodium levels are closely monitored for the first 48 hours. The goal is to prevent overcorrection, which can occur if sodium levels increase too quickly. Overcorrection is defined by specific criteria based on the presence of risk factors.

  5. Step 5

    Additional treatments

    If necessary, additional intravenous solutions such as sodium chloride, potassium chloride, and glucose may be administered to manage the patient's condition. These solutions help maintain the balance of fluids and electrolytes in the body.

  6. Step 6

    Neurological assessment

    The patient's neurological status is evaluated at various intervals, including at 6 hours after treatment initiation. The Glasgow Coma Scale is used to assess consciousness levels.

  7. Step 7

    Follow-up and discharge

    The length of stay in the ICU and hospital is recorded. The patient's recovery and any potential complications, such as central pontine myelinolysis, are monitored. Discharge occurs once the patient's condition stabilizes.

Who can join the trial?

4 criteria

  • Must be an adult (18 years or older).
  • Currently admitted to the ICU (Intensive Care Unit).
  • Have severe hyponatremia, which means a very low level of sodium in the blood. This is defined as having a sodium level less than 120 mmol/L if there are neurological symptoms like seizures, stupor (a state of near-unconsciousness) with a GCS (Glasgow Coma Scale) score less than 12, or signs of brain herniation. Alternatively, a sodium level less than 115 mmol/L without these symptoms.
  • Have a normal or decreased amount of fluid outside the body's cells, known as extracellular fluid volume.

Who cannot join the trial?

1 criterion

  • Patients with severe hyponatremia who are at a high risk of rapid overcorrection of their serum sodium concentration (SNa). Hyponatremia means having a low level of sodium in the blood, and overcorrection refers to increasing the sodium level too quickly, which can be dangerous.
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Investigated drugs

DDAVP is a medication used in this trial to help prevent the overcorrection of low sodium levels in the blood, a condition known as hyponatremia. It works by controlling the amount of water that is removed from the body, which helps to stabilize sodium levels. This trial is investigating whether using DDAVP systematically can reduce the risk of sodium levels rising too quickly in patients with severe hyponatremia.

What is already known about the treatment

DDAVP – This medication is administered intravenously and is used to manage severe hyponatremia, particularly when there is a high risk of rapid correction of serum sodium levels. Currently, DDAVP is being studied in clinical trials to assess its effectiveness in preventing overcorrection of sodium levels in patients with severe hyponatremia. The main therapeutic indication is to stabilize sodium levels in the blood, especially in cases where rapid changes could be harmful. At the molecular level, DDAVP works by mimicking the action of vasopressin, a hormone that helps regulate water balance in the body, thereby influencing sodium concentration. It is classified pharmacologically as a vasopressin analog.

Investigated diseases

Severe Hyponatremia – Severe hyponatremia is a condition characterized by an abnormally low concentration of sodium in the blood. It can lead to symptoms such as nausea, headache, confusion, and in severe cases, seizures or coma. The condition progresses as the body's cells begin to swell due to the imbalance of sodium and water, which can affect brain function. It is often associated with underlying conditions such as chronic alcohol abuse, malnutrition, or the use of certain medications like thiazides or antidepressants. The risk of rapid correction of sodium levels is a concern, as it can lead to complications like central pontine myelinolysis. Monitoring and managing sodium levels carefully is crucial to prevent further complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507254-32-00Protocol codeAPHP220676Estimated enrolment260 patientsSponsorAssistance Publique Hopitaux De Paris

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