Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-26 @ 9:04 PM
Study NCT ID:
NCT06968559
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Early Dexamethasone on Major Complications and All-cause Mortality in Severe Burns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 478}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-02-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-05-05', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major complications', 'timeFrame': '28 days', 'description': "It's a hierarchic procedure. Major complications defined as moderate to severe ARDS (using Berlin definition criteria) or AKI KDIGO 2 to 3 within 28 days"}, {'measure': 'All-cause mortality at day 90', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Hospital-acquired infections', 'timeFrame': '28 days', 'description': 'Hospital-acquired pneumonia (using the joint definition from the Infectious Diseases Society of America and American Thoracic Society) within 28 days'}, {'measure': 'Hospital-acquired infections', 'timeFrame': '28 days', 'description': 'Catheter-related bloodstream infections within 28 daysDiseases Society of America and American Thoracic Society) within 28 days'}, {'measure': 'Hospital-acquired infections', 'timeFrame': '28 days', 'description': 'other infections, including skin infections (diagnosis confirmed by an independent adjudication committee) with or without bacteraemia within 28 days'}, {'measure': 'Hospital-acquired infections', 'timeFrame': '28 days', 'description': 'Antibiotic-free days on day 28'}, {'measure': 'Respiratory complications', 'timeFrame': '28 days', 'description': 'ARDS (using Berlin Criteria definition) on day 28'}, {'measure': 'Respiratory complications', 'timeFrame': '28 days', 'description': 'Invasive ventilator-free days on day 28'}, {'measure': 'ICU Length-of-Stay', 'timeFrame': '28 days', 'description': 'ICU Length-of-Stay'}, {'measure': 'Hospital Length-of-Stay', 'timeFrame': '28 days', 'description': 'Hospital Length-of-Stay'}, {'measure': 'risks of organ dysfunction', 'timeFrame': '14 days', 'description': 'SOFA scores'}, {'measure': 'risks of organ dysfunction', 'timeFrame': '28 days', 'description': 'KDIGO stages 2 and 3 AKI'}, {'measure': 'General tolerance of the treatment', 'timeFrame': '28 days', 'description': 'Number of Participants with Hyperglycemia'}, {'measure': 'specific tolerance of the treatment on skin lesions', 'timeFrame': '28 days', 'description': 'surgical site infections confirmed by an independent adjudication committee,'}, {'measure': 'Timing of first surgery', 'timeFrame': '28 days', 'description': 'Timing of first surgery on the main endpoint'}, {'measure': 'Impact of treatment on serum CRP Levels', 'timeFrame': '14 days', 'description': 'Serum CRP levels on day 0, day 1, day 3, day 7 and day 14'}, {'measure': 'General tolerance of the treatment', 'timeFrame': '28 days', 'description': 'Number of Participants with hypernatremia'}, {'measure': 'General tolerance of the treatment', 'timeFrame': '28 days', 'description': 'Number of Participants with hypokalaemia'}, {'measure': 'General tolerance of the treatment', 'timeFrame': '28 days', 'description': 'Number of Participants with gastrointestinal bleeding'}, {'measure': 'General tolerance of the treatment', 'timeFrame': '28 days', 'description': 'Number of Participants with acquired-weakness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Burns']}, 'descriptionModule': {'briefSummary': 'Burns affect more than 11 million people worldwide each year. These injuries are responsible for severe morbidity resulting in a high societal burden and account for more than 180,000 yearly deaths especially in low- and middle-income countries.\n\nMajor burns induce an important local and systemic inflammatory response that may be overwhelmed. This inflammation is a physiological phenomenon that favours the healing of tissues. However, the overproduction of inflammatory mediators might lead to an exacerbated Systemic Inflammatory Response Syndrome (SIRS). Recently the total body surface area (TBSA) burned has shown to be well correlated to persistent elevation of pro-inflammatory mediators (such as IL-6). This SIRS, in turn, contributes to the enhanced risk of sepsis, acute respiratory distress syndromes (ARDS) and organ failures in general such as acute kidney injuries (AKI), most of those occurring within the first week of admission.\n\nCorticosteroids (CS) have already proven their effectiveness against SIRS-induced organ dysfunction or mortality in acute medicine notably in septic shock, polytraumatized patients and more recently in the treatment of viral or non-viral ARDS without increasing the risk of secondary bacterial complications or significant side effects . Indeed the recent SCCM Guidelines clearly advocate for the use of CS in severe community-acquired pneumonia, septic shock and ARDS. The investigators recently performed a large multicenter, double-blinded randomized controlled trial (the PACMAN trial, PHRC-N 2016) including 1222 patients scheduled for major surgery in which the investigators observed a major decrease in CRP blood concentrations in the dexamethasone arm. The rate of AKI and the need for mechanical ventilation were also significantly reduced in the intervention arm. ICU Patients with severe burns undergo several surgeries, including major procedures (excision, skin grafts), rendering them quite similar to those in the PACMAN trial in terms of inflammatory response. Very few side effects (hyperglycemia mainly) easily overcome in ICU are usually reported with the use of low-to-moderate dose of CS.\n\nIn severe burn patients, very few data are available to date, two retrospective case control studies and a small prospective randomized trial showed promising results when using CS but high quality evidence is lacking.\n\nThe investigators hypothesise here that the use of dexamethasone after major burns, the prototypic model of inflammatory response in surgical ICU patients, would limit SIRS-induced organ failure and/or all-cause mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old ≤ Age ≤ 80 years old.\n* Total burn surface area ≥ 20%, measured by a trained expert upon admission\n* Invasive mechanical ventilation at the time of inclusion\n* Within 48 hours of the burn injury\n* Informed and signed written consent of the next-of-kin, legal representative (trusteeship, guardianship) or emergency procedure in the absence of a legal representative.\n* Affiliation with French social security system or beneficiary from such system\n\nExclusion Criteria:\n\n* Imminent death and a do-not-resuscitate order\n\n * Medical history of hypersensitivity to dexamethasone and hypersensitivity to all of its excipients\n * Pregnancy (attested by a pregnancy test for women of childbearing age) and/or breastfeeding women\n * Participation to another interventional study involving a drug with known interactions with dexamethasone\n * Uncontrolled viral hepatitis or invasive fungal infection at the time of inclusion\n * Prolonged administration of steroids in the last 90 days (\\>0.3 mg/kg/day of equivalent prednisolone)\n * Moderate-to-severe ARDS upon admission (according to Berlin definition criteria)'}, 'identificationModule': {'nctId': 'NCT06968559', 'acronym': 'DEXA-BURN', 'briefTitle': 'Effect of Early Dexamethasone on Major Complications and All-cause Mortality in Severe Burns', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Effect of Early Dexamethasone on Major Complications and All-cause Mortality in Severe Burns', 'orgStudyIdInfo': {'id': 'RC24_0442'}, 'secondaryIdInfos': [{'id': '2024-517708-12-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexamethasone', 'description': 'Dexamethasone 0.2 mg/kg of ideal body weight (IBW) IV (at a maximum of 20 mg per day) will be blindly infused from day 1 to day 5', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo: one IV administration per day from day 1 to day 5.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone 0.2 mg/kg of ideal body weight (IBW) IV (at a maximum of 20 mg per day) will be blindly infused from day 1 to day 5;', 'armGroupLabels': ['Dexamethasone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo: one IV administration per day from day 1 to day 5.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37170', 'city': 'Chambray-lès-Tours', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hugues RAVAUX, Dr', 'role': 'CONTACT', 'email': 'h.ravaux@chu-tours.fr', 'phone': '0247474747'}, {'name': 'Hugues RAVAUX, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '59037', 'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu JEANNE, Dr', 'role': 'CONTACT', 'email': 'mathieu.jeanne@chu-lille.fr', 'phone': '0320445962'}, {'name': 'Mathieu JEANNE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69437', 'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Claire LUKASZEWICZ, Pr', 'role': 'CONTACT', 'email': 'anne-claire.lukaszewicz@chu-lyon.fr', 'phone': '0825082569'}, {'name': 'Anne-Claire LUKASZEWICZ, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13005', 'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'BRUDER Nicolas, Dr', 'role': 'CONTACT', 'email': 'Nicolas.BRUDER@ap-hm.fr', 'phone': '0491380000'}, {'name': 'Nicolas BRUDER, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aphm Hopital La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '57085', 'city': 'Metz', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Boris GLAVNIK, Dr', 'role': 'CONTACT', 'email': 'b.glavnik@chr-metz-thionville.fr', 'phone': '0387553131'}, {'name': 'Boris GLAVNIK, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHR Metz', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Boris JUNG, Pr', 'role': 'CONTACT', 'email': 'b-jung@chu-montpellier.fr', 'phone': '0467336733'}, {'name': 'Boris JUNG, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Karim ASEHNOUNE', 'role': 'CONTACT', 'email': 'Karim.asehnoune@chu-nantes.fr', 'phone': '0240087323'}, {'name': 'Alexandre Bourdiol', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75475', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'François DEPRETS, Dr', 'role': 'CONTACT', 'email': 'François.deprets@aphp.fr', 'phone': '0149956565'}, {'name': 'François Deprets', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HU Saint-Louis Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne- Emmanuelle GAUFICHON, Dr', 'role': 'CONTACT', 'email': 'anne-emmanuelle.gaufichon@chu-bordeaux.fr', 'phone': '0556795679'}, {'name': 'Anne- Emmanuelle GAUFICHON, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier PICHON, Dr', 'role': 'CONTACT', 'email': 'pichon.x@chu-toulouse.fr', 'phone': '0561322533'}, {'name': 'Xavier PICHON, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Karim ASHENOUNE, MD, PhD', 'role': 'CONTACT', 'email': 'karim.asehnoune@chu-nantes.fr', 'phone': '+33 (0)2 53 482 835'}, {'name': 'Alexandre BOURDIOL, PH', 'role': 'CONTACT', 'email': 'alexandre.bourdiol@chu-nantes.fr', 'phone': '+33 (0)2 53 482 217'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}