Ignite Creation Date:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2025-12-30 @ 5:54 AM
Study NCT ID:
NCT06020495
Status:
RECRUITING
Last Update Posted:
2025-05-23
First Post:
2023-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007010', 'term': 'Hyponatremia'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003894', 'term': 'Deamino Arginine Vasopressin'}], 'ancestors': [{'id': 'D001127', 'term': 'Arginine Vasopressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2023-08-28', 'studyFirstSubmitQcDate': '2023-08-28', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reduced occurrence of overcorrection of serum sodium concentration (SNa) in the first 48 hours after randomization', 'timeFrame': '48 hours after the randomization', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'the reversal of acute neurological symptoms in patients with neurological symptoms at inclusion', 'timeFrame': '6 hours after the randomization', 'description': 'proportion of patients with neurological symptoms at inclusion and who subsequently have a normal Glasgow Coma Scale at H6'}, {'measure': 'ICU and hospital length of stay', 'timeFrame': 'ICU or hospital discharge', 'description': 'length of ICU and hospital stay'}, {'measure': 'survival', 'timeFrame': 'death after randomization', 'description': 'time to death after inclusion'}, {'measure': 'the occurrence of central pontine myelinolysis diagnosed on clinical and MRI criteria', 'timeFrame': '15 days after randomization', 'description': 'proportion of patients with the occurrence of central pontine myelinolysis diagnosed on clinical and MRI criteria at day 15 (or earlier if clinically justified)'}, {'measure': 'the occurrence of any (pontine or extrapontine) osmotic demyelination as assessed by brain MRI', 'timeFrame': '15 days after randomization', 'description': 'proportion of patients with any (pontine or extrapontine), symptomatic or not, osmotic demyelination as assessed by brain MRI at day 15 (or earlier if clinically justified)'}, {'measure': 'on the percentage of patients with neurological symptoms at inclusion and reaching the initial goal of rapid partial pre-defined correction of SNa level', 'timeFrame': '6 hours after the randomization', 'description': 'proportion of patients with neurological symptoms with an increase of 5.0 mmol/L or more of SNa from inclusion to H6'}, {'measure': 'the urine output between H0 and H6', 'timeFrame': '6 hours after the randomization', 'description': 'urine output between H0 and H6'}, {'measure': 'the urine output between H6 and H12', 'timeFrame': '12 hours after the randomization', 'description': 'urine output between H6 and H12'}, {'measure': 'the urine output between H12 and H24', 'timeFrame': '24 hours after the randomization', 'description': 'urine output between H12 and H24'}, {'measure': 'the urine output between H24 and H48', 'timeFrame': '48 hours after the randomization', 'description': 'urine output between H24 and H48'}, {'measure': 'the urine osmolality between H0 and H6', 'timeFrame': '6 hours after the randomization', 'description': 'urine osmolality between H0 and H6'}, {'measure': 'the urine osmolality between H6 and H12', 'timeFrame': '12 hours after the randomization', 'description': 'urine osmolality between H6 and H12'}, {'measure': 'the urine osmolality between H12 and H24', 'timeFrame': '24 hours after the randomization', 'description': 'urine osmolality between H12 and H24'}, {'measure': 'the urine osmolality between H24 and H48', 'timeFrame': '48 hours after the randomization', 'description': 'urine osmolality between H24 and H48'}, {'measure': 'SNa level correction rate between H0 and H24', 'timeFrame': '24 hours after the randomization', 'description': 'slope of the SNa increase between H0 and H24'}, {'measure': 'SNa level correction rate between H0 and H48', 'timeFrame': '48 hours after the randomization', 'description': 'slope of the SNa increase between H0 and H48'}, {'measure': 'the maximal change of SNa level between H0 and H24', 'timeFrame': '24 hours after the randomization', 'description': 'maximum change of SNa from baseline between H0 and H24'}, {'measure': 'the maximal change of SNa level between H0 and H48', 'timeFrame': '48 hours after the randomization', 'description': 'maximum change of SNa from baseline between H0 and H48'}, {'measure': 'amount of hypotonic fluids administration', 'timeFrame': '24 hours after the randomization', 'description': 'total amount of intravenous hypotonic fluids administered between H0 and H24'}, {'measure': 'amount of hypotonic fluids administration', 'timeFrame': '48 hours after the randomization', 'description': 'total amount of intravenous hypotonic fluids administered between H0 and H48'}, {'measure': 'amount of sodium and potassium administered between H0 and H24', 'timeFrame': '24 hours after the randomization', 'description': 'total amount of sodium and potassium administered between H0 and H24'}, {'measure': 'amount of sodium and potassium administered between H0 and H48', 'timeFrame': '48 hours after the randomization', 'description': 'total amount of sodium and potassium administered between H0 and H48'}, {'measure': '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', 'timeFrame': '28 days after randomization', 'description': 'proportion of patients with seizures, stupor or sign of brain herniation appearing or reappearing after inclusion'}, {'measure': 'the occurrence of excessive re-lowering of sodium', 'timeFrame': '48 hours after the randomization', 'description': 'Occurrence of a reduction of SNa of 5.0 mmol/L or more from inclusion between H0 and H48'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyponatremia']}, 'descriptionModule': {'briefSummary': 'ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.', 'detailedDescription': '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).\n\nPatients in ICU with severe hyponatremia defined by SNa \\< 115 mmol/L or SNa \\< 120 mmol/L in the presence of neurological symptoms (convulsions, stupor defined by a Glasgow score \\<12 or signs of brain herniation) and a normal or decreased extracellular fluid volume will be included.\n\nAfter 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 \\<12 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ( ≥18 years)\n* Current admission in ICU\n* 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\n* Normal or decreased extracellular fluid volume\n\nExclusion Criteria:\n\n* Obvious increase of extracellular fluid volume (cirrhosis with ascites, congestive heart failure, nephrotic syndrome);\n* Hyponatremia caused by hyperglycaemia (\\> 30 mmol/L) or hypertriglyceridemia (10 g/L) or hyperproteinaemia (120 g/L)\n* Severe acute kidney injury (KDIGO 3)\n* Severe chronic kidney disease (eGFR \\<20 ml/min)\n* Coronary patients well stabilized with trinitrine-based medicines\n* Recent neurosurgery or traumatic brain injury\n* Previous DDAVP or hypertonic fluid administration for the current episode of severe hyponatremia\n* SNa increased by 5 mmol or more between admission at hospital and randomisation (H0)\n* Known contraindication to DDAVP\n\n * Allergy\n * Syndrome of inappropriate antidiuretic hormone secretion (SIADH)\n * History of unstable angina and/or known or suspected heart failure.\n * Willebrand disease type IIB\n* Severe previous neurologic disability (Glasgow Outcome Scale: GOS \\< 3)\n* Diabetes insipidus receiving DDAVP treatment\n* Moribund state (patient likely to die within 24h)\n* Need for invasive mechanic ventilation\n* Enrolment to another interventional study (clinical trial on medicinal product, medical device and interventional research involving human participants not concerning health product)\n* Pregnancy or breastfeeding\n* Subject deprived of freedom, subject under a legal protective measure\n* No affiliation to any health insurance system\n* Refusal to participate to the study (patient or legal representative or family member or close relative if present)'}, 'identificationModule': {'nctId': 'NCT06020495', 'acronym': 'DASSOH', 'briefTitle': 'Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia: a Multicenter Open-label Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'APHP220676'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DDAVP', 'description': 'DDAVP 4µg/ml IV Additional doses may be administrated every 6h for a maximum of 48h\n\n\\- 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', 'interventionNames': ['Drug: DDAVP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard hyponatremia treatment', 'description': 'Standard hyponatremia treatment alone :\n\nPresence of neurological symptoms : sodium chloride 3% 150ml for 20 min Absence of neurological symptoms : Hyper or isotonic fluid but never hypotonic', 'interventionNames': ['Drug: Standard hyponatremia treatment']}], 'interventions': [{'name': 'DDAVP', 'type': 'DRUG', 'description': 'Posology: 4µg in 2ml IV solution Route of administration: Intravenous Duration of treatment: 48h maximum (additional doses every 6h)', 'armGroupLabels': ['DDAVP']}, {'name': 'Standard hyponatremia treatment', 'type': 'DRUG', 'description': 'Standard hyponatremia treatment alone :\n\nPresence of neurological symptoms :\n\nsodium chloride 3% 150ml for 20 min Absence of neurological symptoms : Hyper or isotonic fluid but never hypotonic', 'armGroupLabels': ['Standard hyponatremia treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien MAIZEL', 'role': 'CONTACT', 'email': 'maizel.julien@chu-amiens.fr'}, {'name': 'Julien MAIZEL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Médecine Intensive et Réanimation - Centre Hospitalier Universitaire Amiens-Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '93000', 'city': 'Bobigny', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas BONNET', 'role': 'CONTACT', 'email': 'nicolas.bonnet@aphp.fr'}, {'name': 'Nicolas BONNET', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Médecine Intensive et Réanimation - Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'city': 'Bondy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Khalil CHAIBI, MD', 'role': 'CONTACT'}, {'name': 'Khalil CHAIBI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Réanimation Polyvalente - Hôpital Jean Verdier', 'geoPoint': {'lat': 48.9018, 'lon': 2.48931}}, {'zip': '92700', 'city': 'Colombes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabrice UHEL', 'role': 'CONTACT', 'email': 'fabrice.uhel@aphp.fr'}, {'name': 'Fabrice UHEL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Médecine Intensive et Réanimation - Hôpital Louis Mourier', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '91100', 'city': 'Corbeil-Essonnes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume CHEVREL', 'role': 'CONTACT', 'email': 'guillaume.chevrel@chsf.fr'}, {'name': 'Guillaume CHEVREL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Réanimation Polyvalente et Surveillance continue - Centre Hospitalier Sud Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}, {'zip': '94000', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas DE PROST', 'role': 'CONTACT', 'email': 'nicolas.de-prost@aphp.fr'}, {'name': 'Nicolas DE PROST', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Médecine Intensive et Réanimation - Hôpital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21079', 'city': 'Dijon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Pierre QUENOT', 'role': 'CONTACT', 'email': 'jean-pierre.quenot@chu-dijon.fr'}, {'name': 'Jean-Pierre QUENOT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Médecine Intensive et Réanimation - Hôpital François Mitterand', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '85000', 'city': 'La Roche-sur-Yon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent MARTIN LEFEVRE', 'role': 'CONTACT', 'email': 'laurent.martin-lefevre@chd-vendee.fr', 'phone': '02 51 44 60 88'}, {'name': 'Laurent MARTIN LEFEVRE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Réanimation Polyvalente - Centre Hospitalier Départemental Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '91160', 'city': 'Longjumeau', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Matthieu LE MEUR', 'role': 'CONTACT', 'email': 'm.lemeur@gh-nord-essonne.fr', 'phone': '01 64 54 30 30'}, {'name': 'Matthieu LE MEUR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Réanimation Médicale - Hôpital de Longjumeau', 'geoPoint': {'lat': 48.69307, 'lon': 2.29431}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien MAYAUX', 'role': 'CONTACT', 'email': 'julien.mayaux@aphp.fr'}, {'name': 'Julien MAYAUX', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '93200', 'city': 'Saint-Denis', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Daniel DA SILVA', 'role': 'CONTACT', 'email': 'daniel.silva@ch-stdenis.fr'}, {'name': 'Daniel DA SILVA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Médecine Intensive Réanimation - Hôpital Delafontaine', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '92150', 'city': 'Suresnes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benjamin ZUBER', 'role': 'CONTACT', 'email': 'b.zuber@hopital-foch.com'}, {'name': 'Benjamin ZUBER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Réanimation Polyvalente - Hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'centralContacts': [{'name': 'GAUDRY Stéphane', 'role': 'CONTACT', 'email': 'stephane.gaudry@aphp.fr', 'phone': '01.48.95.55.55'}, {'name': 'DECHANET Aline', 'role': 'CONTACT', 'email': 'aline.dechanet@aphp.fr', 'phone': '01 40 25 78 30'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}