Nctid:
NCT06226402
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012128", "term"=>"Respiratory Distress Syndrome"}, {"id"=>"D012127", "term"=>"Respiratory Distress Syndrome, Newborn"}, {"id"=>"D055371", "term"=>"Acute Lung Injury"}, {"id"=>"D013577", "term"=>"Syndrome"}], "ancestors"=>[{"id"=>"D004194", "term"=>"Disease"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D008171", "term"=>"Lung Diseases"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D012120", "term"=>"Respiration Disorders"}, {"id"=>"D007235", "term"=>"Infant, Premature, Diseases"}, {"id"=>"D007232", "term"=>"Infant, Newborn, Diseases"}, {"id"=>"D055370", "term"=>"Lung Injury"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "asFound"=>"Syndrome", "relevance"=>"HIGH"}, {"id"=>"M28144", "name"=>"Acute Lung Injury", "asFound"=>"Acute Respiratory Distress Syndrome", "relevance"=>"HIGH"}, {"id"=>"M14965", "name"=>"Respiratory Distress Syndrome", "asFound"=>"Respiratory Distress Syndrome", "relevance"=>"HIGH"}, {"id"=>"M14964", "name"=>"Respiratory Distress Syndrome, Newborn", "asFound"=>"Respiratory Distress Syndrome", "relevance"=>"HIGH"}, {"id"=>"M28143", "name"=>"Lung Injury", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M14957", "name"=>"Respiration Disorders", "relevance"=>"LOW"}, {"id"=>"M25869", "name"=>"Premature Birth", "relevance"=>"LOW"}, {"id"=>"M10279", "name"=>"Infant, Premature, Diseases", "relevance"=>"LOW"}, {"id"=>"M10276", "name"=>"Infant, Newborn, Diseases", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T192", "name"=>"Acute Respiratory Distress Syndrome", "asFound"=>"Acute Respiratory Distress Syndrome", "relevance"=>"HIGH"}, {"id"=>"T4927", "name"=>"Respiratory Distress Syndrome, Infant", "asFound"=>"Respiratory Distress Syndrome", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4854", "name"=>"Benzocaine", "relevance"=>"LOW"}, {"id"=>"T433", "name"=>"Tannic Acid", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>105}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-09-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-09-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-17", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-09-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Number of patients who will need mechanical ventilation", "timeFrame"=>"28 days after intervention", "description"=>"Number of patients who will need mechanical ventilation will be assessed."}], "secondaryOutcomes"=>[{"measure"=>"Length of ICU stay", "timeFrame"=>"28 days after intervention", "description"=>"Length of ICU stay will be measured from the admission till the discharge from the hospital."}, {"measure"=>"Lung injury score (Murray score)", "timeFrame"=>"24 hours after intervention", "description"=>"Murray score (lung injury score) will be calculated daily in the morning based on information obtained from:\n\n1. Number of quadrants of infiltrations from chest X-ray.\n2. Hypoxic index.\n3. Positive end expiratory pressure (PEEP) required on the ventilator to get better oxygenation.\n4. Static compliance."}, {"measure"=>"Incidence of mortality", "timeFrame"=>"28 days after intervention", "description"=>"Incidence of mortality will be assessed at 7th, and 28th day."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Nebulization", "Hypertonic Saline", "Acute Respiratory Distress Syndrome"]}, "descriptionModule"=>{"briefSummary"=>"The aim of our study is to compare between the effect of nebulized and intravenous injection of hypertonic saline 3% on the outcome of patients with acute respiratory distress syndrome.", "detailedDescription"=>"Acute Respiratory Distress Syndrome (ARDS) is a life threatening form of respiratory failure, characterized by acute, diffuse, inflammatory lung injury that results in increased alveolar capillary permeability and the development of non-hydrostatic pulmonary edema.\n\nClinically, ARDS manifests as marked hypoxemia and respiratory distress; patients often progress to respiratory failure that requires invasive mechanical ventilation in the intensive care unit.\n\nNo specific pharmacological treatment is available for ARDS, which is associated with high morbidity and mortality. The mainstay of therapy in ARDS is supportive therapy and invasive mechanical ventilation based on lung-protective strategies using low tidal volume (VT) at 4-6 ml/kg of predicted body weight (PBW) and plateau pressure (p PLAT) below 30 cm H2O, but other adjunctive therapies have been trialed with various degrees of efficacy, including neuromuscular blockade, prone positioning, recruitment maneuvers (RMs), vasodilators, and extracorporeal membrane oxygenation (ECMO).\n\nHypertonic saline 3% NaCl with 513 mEq/L of Na and 513 mEq/L of Cl is a potent anti-inflammatory agent, and immunomodulator, which exerts inhibitory effects in several stages of the inflammatory cascade. Hypertonic saline, at a cellular level, decreases alveolar macrophage activation, polymorph nuclear leucocyte recruitment, priming and activation, as well as cell surface adhesion molecule expression. High plasma sodium contributes to high plasma osmolality which can be lung protective and would seem to be a logical choice for treatment of ARDS."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"21 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age from 21 to 60 years old.\n* Both sexes.\n* Patients with mild and moderate ARDS whose PaO2/FiO2 ratio ≥ 150 according to the Berlin definition of Acute Respiratory Distress Syndrome.\n\nExclusion Criteria:\n\n* Refusal to participate in the study.\n* Malignancy.\n* Patients on chemotherapy.\n* Decompensated renal, hepatic and cardiac disease.\n* Patients with hypernatremia whose serum Na above 155 mEq/L.\n* Patients with ARDS whose PaO2/FiO2 ratio \\> 150."}, "identificationModule"=>{"nctId"=>"NCT06226402", "briefTitle"=>"Effect of Nebulized and Intravenous Hypertonic Saline 3% on the Management of Patients With Acute Respiratory Distress Syndrome", "organization"=>{"class"=>"OTHER", "fullName"=>"Tanta University"}, "officialTitle"=>"Comparative Study Between the Effect of Nebulized and Intravenous Hypertonic Saline 3% on the Management of Patients With Acute Respiratory Distress Syndrome", "orgStudyIdInfo"=>{"id"=>"36264MS225/6/23"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"NO_INTERVENTION", "label"=>"Control group", "description"=>"Patients will receive the standard pharmacotherapy of Acute Respiratory Distress Syndrome (ARDS) patients."}, {"type"=>"EXPERIMENTAL", "label"=>"Inhalational group", "description"=>"Patients will receive the standard pharmacotherapy + hypertonic saline 3% (5ml) nebulizer /8hr.", "interventionNames"=>["Drug: Hypertonic saline 3% nebulizer"]}, {"type"=>"EXPERIMENTAL", "label"=>"Intravenous group", "description"=>"Patients will receive the standard pharmacotherapy + hypertonic saline 3% intravenous over 24 hours to maintain plasma Na level between 145-150 mEq/L.", "interventionNames"=>["Drug: Intravenous hypertonic saline 3%"]}], "interventions"=>[{"name"=>"Hypertonic saline 3% nebulizer", "type"=>"DRUG", "description"=>"Patients will receive the standard pharmacotherapy + hypertonic saline 3% (5ml) nebulizer /8hr.", "armGroupLabels"=>["Inhalational group"]}, {"name"=>"Intravenous hypertonic saline 3%", "type"=>"DRUG", "description"=>"Patients will receive the standard pharmacotherapy + hypertonic saline 3% intravenous over 24 hours to maintain plasma Na level between 145-150 mEq/L.", "armGroupLabels"=>["Intravenous group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"31527", "city"=>"Tanta", "state"=>"El-Gharbia", "status"=>"RECRUITING", "country"=>"Egypt", "contacts"=>[{"name"=>"Mohamed E Elfakhrany, MBBCH", "role"=>"CONTACT", "email"=>"mohamed169729_pg@med.tanta.edu.eg", "phone"=>"00201023825321"}, {"name"=>"Sabry M Ameen, MD", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Jehan M Darwish, MD", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Taysser M Abdalraheem, MD", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"Tanta University", "geoPoint"=>{"lat"=>30.78847, "lon"=>31.00192}}], "centralContacts"=>[{"name"=>"Mohamed E Elfakhrany, MBBCH", "role"=>"CONTACT", "email"=>"mohamed169729_pg@med.tanta.edu.eg", "phone"=>"00201023825321"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL"], "timeFrame"=>"After the end of study for one year.", "ipdSharing"=>"YES", "description"=>"The data will be available upon a reasonable request from the corresponding author after the end of study for one year.", "accessCriteria"=>"The data will be available upon a reasonable request from the corresponding author."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Tanta University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.", "investigatorFullName"=>"Mohamed Elsayed Mohamed Elfakhrany", "investigatorAffiliation"=>"Tanta University"}}}}
