HyponatremiaPhase 3DASSOHNCT06020495
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
A Phase 3 study testing DDAVP and Standard hyponatremia treatment in people with Hyponatremia, run by Assistance Publique - Hôpitaux de Paris at 15 sites in France.
Trial summary
ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia
- What is being tested?
- DDAVP and Standard hyponatremia treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 15 sitesFrance
- Study dates
- 17 Dec 2024to Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ( ≥18 years)
- Current admission in ICU
- Severe hyponatremia defined by SNa <120 mmol/L in the presence of neurological symptoms (seizures, confusion defined as Glasgow score <= 14, or signs of brain herniation) or by SNa <115 mmol/L
- Normal or decreased extracellular fluid volume
Who cannot join
- 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)
- Coronary patients well stabilized with trinitrine-based medicines
- Recent neurosurgery or traumatic brain injury
Show all 22Show fewer
- Previous DDAVP or hypertonic fluid administration for the current episode of severe hyponatremia
- SNa increased by 5 mmol or more between admission at hospital and randomisation (H0)
- Known contraindication to DDAVP
- Allergy
- Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
- History of unstable angina and/or known or suspected heart failure.
- Willebrand disease type IIB
- Severe previous neurologic disability (Glasgow Outcome Scale: GOS < 3)
- Diabetes insipidus receiving DDAVP treatment
- Moribund state (patient likely to die within 24h)
- Need for invasive mechanic ventilation
- Enrolment to another interventional study (clinical trial on medicinal product, medical device and interventional research involving human participants not concerning health product)
- Pregnancy or breastfeeding
- Subject deprived of freedom, subject under a legal protective measure
- No affiliation to any health insurance system
- Refusal to participate to the study (patient or legal representative or family member or close relative if present)
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
France15 sites, 15 recruiting
- Recruiting
Médecine Intensive et Réanimation - Centre Hospitalier Universitaire Amiens-Picardie
Amiens, 80054
Julien MAIZEL, maizel.julien@chu-amiens.fr
Julien MAIZEL
- Not yet recruiting
Néphrologie, dialyse et transplantation - Service de médecine intensive Réanimation, CHU Amiens-Picardie
Amiens, 80054
Dimitri TITECA, titeca.dimitri@chu-amiens.fr
Dimitri TITECA
- Recruiting
Médecine Intensive et Réanimation - Hôpital Avicenne
Bobigny, 93000
Nicolas BONNET, nicolas.bonnet@aphp.fr
Nicolas BONNET
- Recruiting
Réanimation Polyvalente - Hôpital Jean Verdier
Bondy
Nathan EBSTEIN, MD, nathan.ebstein@aphp.fr
Nathan EBSTEIN, MD
- Recruiting
Médecine Intensive et Réanimation - Hôpital Louis Mourier
Colombes, 92700
Fabrice UHEL, fabrice.uhel@aphp.fr
Fabrice UHEL
- Recruiting
Réanimation Polyvalente et Surveillance continue - Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100
Guillaume CHEVREL, guillaume.chevrel@chsf.fr
Guillaume CHEVREL
- Recruiting
Médecine Intensive et Réanimation - Hôpital Henri Mondor
Créteil, 94000
Romain ARRESTIER, romain.arrestier@aphp.fr
Romain ARRESTIER
- Not yet recruiting
Service de néphrologie - Soins intensifs - Dialyse - Transplantation, CHU Dijon
Dijon, 21000
Pierre-Henri BONNOT, pierrehenri.bonnot@chu-dijon.fr
Pierre-Henri BONNOT
- Recruiting
Médecine Intensive et Réanimation - Hôpital François Mitterand
Dijon, 21079
Jean-Pierre QUENOT, jean-pierre.quenot@chu-dijon.fr
Jean-Pierre QUENOT
- Recruiting
Réanimation Polyvalente - Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85000
Laurent MARTIN LEFEVRE, 02 51 44 60 88, laurent.martin-lefevre@chd-vendee.fr
Laurent MARTIN LEFEVRE
- Recruiting
Réanimation Polyvalente, CHR Metz Thionville - Hôpital de Mercy
Metz, 57085
Guillaume LOUIS, guillaume.louis@chr-metz-thionville.fr
Guillaume LOUIS
- Recruiting
Réanimation Médicale - Hôpital de Paris Saclay
Orsay, 91400
Matthieu LE MEUR, 01 64 54 30 30, m.lemeur@gh-nord-essonne.fr
Matthieu LE MEUR
- Recruiting
Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière
Paris, 75013
Julien MAYAUX, julien.mayaux@aphp.fr
Julien MAYAUX
- Recruiting
Médecine Intensive Réanimation - Hôpital Delafontaine
Saint-Denis, 93200
Nolan HASSOLD-RUGOLINO, nolan.hassold@ch-stdenis.fr
Nolan HASSOLD-RUGOLINO
- Recruiting
Réanimation Polyvalente - Hôpital Foch
Suresnes, 92150
Benjamin ZUBER, b.zuber@hopital-foch.com
Benjamin ZUBER
About this study
Official title: Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia: a Multicenter Open-label Randomized Controlled Trial
ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.
Read the detailed description
Multicentre, prospective, open-label randomized controlled superiority trial with stratification on the presence of neurological symptoms at inclusion and on the presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse, malnutrition, serum potassium < 3.0 mmol/L).
Patients in ICU with severe hyponatremia defined by SNa < 115 mmol/L or SNa < 120 mmol/L in the presence of neurological symptoms (convulsions, confusion defined by a Glasgow score <=14 or signs of brain herniation) and a normal or decreased extracellular fluid volume will be included.
After written informed consent, they will be randomized (1:1), using a computer-generated randomization scheme of various-sized blocks, stratified by the presence of neurological symptoms at inclusion (seizures, stupor defined as Glasgow score <=14 or signs of brain herniation) and on the presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse [defined according to World Health Organization definition], malnutrition [BMI<20.5 or weight loss >5% in 3 months], serum potassium < 3.0 mmol/L), through a centralized 24-hour Internet service (CleanWEB™), to receive standard hyponatremic treatment alone or standard hyponatremic treatment and DDAVP 4 μg/ml IV, after randomisation and for a total duration of 48 hours. Since administration of DDAVP leads to an important decrease in urine output and increase in urine osmolarity which are clinically obvious very rapidly, a single or double blind trial is not appropriate. 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
- Conditions
- Hyponatremia
- Being tested
- DDAVP, Standard hyponatremia treatment
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDAVPDrug
Posology: 4µg in 2ml IV solution Route of administration: Intravenous Duration of treatment: 48h maximum (additional doses every 6h)
Standard hyponatremia treatmentDrug
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
| Study group | Role | What they receive |
|---|---|---|
| DDAVP | Experimental | DDAVP 4µg/ml IV Additional doses may be administrated every 6h for a maximum of 48h
- Standard hyponatremia treatment : Presence of neurological symptoms : sodium chloride 3% 150ml for 20 min Absence of neurological symptoms : Hyper or isotonic fluid but never hypotonic Receives: Drug: DDAVP |
| Standard hyponatremia treatment | Active comparator | 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 Receives: Drug: Standard hyponatremia treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours after the randomization
Secondary outcomes (28)
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
Measured: 6 hours after the randomization
ICU and hospital length of stay
length of ICU and hospital stay
Measured: ICU or hospital discharge
survival
time to death after inclusion
Measured: death after randomization
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 + 5 days (or earlier if clinically justified)
Measured: 15 days + 5 days after randomization
the occurrence of any (pontine or extrapontine) osmotic demyelination as assessed by brain MRI
proportion of patients with any (pontine or extrapontine), symptomatic or not, osmotic demyelination as assessed by brain MRI at day 15 + 5 days (or earlier if clinically justified)
Measured: 15 days + 5 days after randomization
on the percentage of patients with neurological symptoms at inclusion and reaching the initial goal of rapid partial pre-defined correction of SNa level
proportion of patients with neurological symptoms with an increase of 5.0 mmol/L or more of SNa from inclusion to H6
Measured: 6 hours after the randomization
the urine output between H0 and H6
urine output between H0 and H6
Measured: 6 hours after the randomization
the urine output between H6 and H12
urine output between H6 and H12
Measured: 12 hours after the randomization
the urine output between H12 and H24
urine output between H12 and H24
Measured: 24 hours after the randomization
the urine output between H24 and H48
urine output between H24 and H48
Measured: 48 hours after the randomization
the urine osmolality between H0 and H6
urine osmolality between H0 and H6
Measured: 6 hours after the randomization
the urine osmolality between H6 and H12
urine osmolality between H6 and H12
Measured: 12 hours after the randomization
the urine osmolality between H12 and H24
urine osmolality between H12 and H24
Measured: 24 hours after the randomization
the urine osmolality between H24 and H48
urine osmolality between H24 and H48
Measured: 48 hours after the randomization
SNa level correction rate between H0 and H24
slope of the SNa increase between H0 and H24
Measured: 24 hours after the randomization
SNa level correction rate between H0 and H48
slope of the SNa increase between H0 and H48
Measured: 48 hours after the randomization
the maximal change of SNa level between H0 and H24
maximum change of SNa from baseline between H0 and H24
Measured: 24 hours after the randomization
the maximal change of SNa level between H0 and H48
maximum change of SNa from baseline between H0 and H48
Measured: 48 hours after the randomization
the change of serum renin, apelin, Co-peptin and aldosterone concentration level between H0 and H6
change of serum renin, apelin, Co-peptin and aldosterone concentrations from baseline H0 and H6
Measured: 6 hours after the randomization
the change of serum renin, apelin, Co-peptin and aldosterone concentration level between H6 and H24
change of serum renin, apelin, Co-peptin and aldosterone concentrations from baseline H6 and H24
Measured: between 6 and 24 hours after the randomization
the change of serum renin, apelin, Co-peptin and aldosterone concentration level between H0 and H24
change of serum renin, apelin, Co-peptin and aldosterone concentrations from baseline H0 and H24
Measured: 24 hours after the randomization
the change of serum renin, apelin, Co-peptin and aldosterone concentration level between H24 and H48
change of serum renin, apelin, Co-peptin and aldosterone concentrations from baseline H24 and H48
Measured: between 24 and 48 hours after the randomization
amount of hypotonic fluids administration
total amount of intravenous hypotonic fluids administered between H0 and H24
Measured: 24 hours after the randomization
amount of hypotonic fluids administration
total amount of intravenous hypotonic fluids administered between H0 and H48
Measured: 48 hours after the randomization
amount of sodium and potassium administered between H0 and H24
total amount of sodium and potassium administered between H0 and H24
Measured: 24 hours after the randomization
amount of sodium and potassium administered between H0 and H48
total amount of sodium and potassium administered between H0 and H48
Measured: 48 hours after the randomization
the occurrence of any new neurological sign in relation with hyponatremia in patients with a normal neurological exam at inclusion or on the reappearance of any neurological sign in relation with hyponatremia after inclusion
proportion of patients with seizures,confusion or sign of brain herniation appearing or reappearing after inclusion
Measured: 28 days after randomization
the occurrence of excessive re-lowering of sodium
Occurrence of a reduction of SNa of 5.0 mmol/L or more from inclusion between H0 and H48
Measured: 48 hours after the randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start17 Dec 2024
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, prospective, open-label randomized controlled superiority trial with stratification on the presence of neurological symptoms at inclusion and on the presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse, malnutrition, serum potassium \< 3.0 mmol/L).
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020495
- Sponsor's protocol ID
- APHP220676
- Acronym
- DASSOH
- Status last verified
- Jul 2026
- First submitted
- 28 Aug 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia: a Multicenter Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06020495
- Acronym / sponsor ID
- DASSOH / APHP220676
- Conditions
- Hyponatremia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.
Detailed description
Multicentre, prospective, open-label randomized controlled superiority trial with stratification on the presence of neurological symptoms at inclusion and on the presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse, malnutrition, serum potassium < 3.0 mmol/L).
Patients in ICU with severe hyponatremia defined by SNa < 115 mmol/L or SNa < 120 mmol/L in the presence of neurological symptoms (convulsions, confusion defined by a Glasgow score <=14 or signs of brain herniation) and a normal or decreased extracellular fluid volume will be included.
After written informed consent, they will be randomized (1:1), using a computer-generated randomization scheme of various-sized blocks, stratified by the presence of neurological symptoms at inclusion (seizures, stupor defined as Glasgow score <=14 or signs of brain herniation) and on the presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse [defined according to World Health Organization definition], malnutrition [BMI<20.5 or weight loss >5% in 3 months], serum potassium < 3.0 mmol/L), through a centralized 24-hour Internet service (CleanWEB™), to receive standard hyponatremic treatment alone or standard hyponatremic treatment and DDAVP 4 μg/ml IV, after randomisation and for a total duration of 48 hours. Since administration of DDAVP leads to an important decrease in urine output and increase in urine osmolarity which are clinically obvious very rapidly, a single or double blind trial is not appropriate. 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre, prospective, open-label randomized controlled superiority trial with stratification on the presence of neurological symptoms at inclusion and on the presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse, malnutrition, serum potassium < 3.0 mmol/L).
| Arm | Type | Receives |
|---|---|---|
| DDAVP | Experimental | Drug: DDAVPDDAVP 4µg/ml IV Additional doses may be administrated every 6h for a maximum of 48h - Standard hyponatremia treatment : Presence of neurological symptoms : sodium chloride 3% 150ml for 20 min Absence of neurological symptoms : Hyper or isotonic fluid but never hypotonic |
| Standard hyponatremia treatment | Active comparator | Drug: Standard hyponatremia treatmentStandard 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ( ≥18 years)
- Current admission in ICU
- Severe hyponatremia defined by SNa <120 mmol/L in the presence of neurological symptoms (seizures, confusion defined as Glasgow score <= 14, or signs of brain herniation) or by SNa <115 mmol/L
- Normal or decreased extracellular fluid volume
Key exclusion criteria (22 listed)
- 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)
- Coronary patients well stabilized with trinitrine-based medicines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DDAVPPosology: 4µg in 2ml IV solution Route of administration: Intravenous Duration of treatment: 48h maximum (additional doses every 6h) | Drug | DDAVP |
| Standard hyponatremia treatmentStandard 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 | Drug | Standard hyponatremia treatment |
Primary outcome
reduced occurrence of overcorrection of serum sodium concentration (SNa) in the first 48 hours after randomization
Time frame: 48 hours after the 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
28 secondary outcomes
the reversal of acute neurological symptoms in patients with neurological symptoms at inclusion
Time frame: 6 hours after the randomization
ICU and hospital length of stay
Time frame: ICU or hospital discharge
survival
Time frame: death after randomization
the occurrence of central pontine myelinolysis diagnosed on clinical and MRI criteria
Time frame: 15 days + 5 days after randomization
the occurrence of any (pontine or extrapontine) osmotic demyelination as assessed by brain MRI
Time frame: 15 days + 5 days after randomization
on the percentage of patients with neurological symptoms at inclusion and reaching the initial goal of rapid partial pre-defined correction of SNa level
Time frame: 6 hours after the randomization
the urine output between H0 and H6
Time frame: 6 hours after the randomization
the urine output between H6 and H12
Time frame: 12 hours after the randomization
the urine output between H12 and H24
Time frame: 24 hours after the randomization
the urine output between H24 and H48
Time frame: 48 hours after the randomization
the urine osmolality between H0 and H6
Time frame: 6 hours after the randomization
the urine osmolality between H6 and H12
Time frame: 12 hours after the randomization
the urine osmolality between H12 and H24
Time frame: 24 hours after the randomization
the urine osmolality between H24 and H48
Time frame: 48 hours after the randomization
SNa level correction rate between H0 and H24
Time frame: 24 hours after the randomization
SNa level correction rate between H0 and H48
Time frame: 48 hours after the randomization
the maximal change of SNa level between H0 and H24
Time frame: 24 hours after the randomization
the maximal change of SNa level between H0 and H48
Time frame: 48 hours after the randomization
the change of serum renin, apelin, Co-peptin and aldosterone concentration level between H0 and H6
Time frame: 6 hours after the randomization
the change of serum renin, apelin, Co-peptin and aldosterone concentration level between H6 and H24
Time frame: between 6 and 24 hours after the randomization
the change of serum renin, apelin, Co-peptin and aldosterone concentration level between H0 and H24
Time frame: 24 hours after the randomization
the change of serum renin, apelin, Co-peptin and aldosterone concentration level between H24 and H48
Time frame: between 24 and 48 hours after the randomization
amount of hypotonic fluids administration
Time frame: 24 hours after the randomization
amount of hypotonic fluids administration
Time frame: 48 hours after the randomization
amount of sodium and potassium administered between H0 and H24
Time frame: 24 hours after the randomization
amount of sodium and potassium administered between H0 and H48
Time frame: 48 hours after the randomization
the occurrence of any new neurological sign in relation with hyponatremia in patients with a normal neurological exam at inclusion or on the reappearance of any neurological sign in relation with hyponatremia after inclusion
Time frame: 28 days after randomization
the occurrence of excessive re-lowering of sodium
Time frame: 48 hours after the randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DDAVP and Standard hyponatremia treatment in people with Hyponatremia, run by Assistance Publique - Hôpitaux de Paris at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GAUDRY Stéphane (01.48.95.55.55, stephane.gaudry@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduced occurrence of overcorrection of serum sodium concentration (SNa) in the first 48 hours after randomization (time frame: 48 hours after the randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.