[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643117":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":56,"studyPopulation":56,"armGroups":63,"interventions":110,"overallOfficials":56,"centralContacts":125,"locations":131,"responsibleParty":150,"collaborators":56,"id":154,"slug":56,"hasResults":155,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":161,"sex":162,"minAge":163,"maxAge":164,"enrollmentInfo":165,"targetDuration":56,"studyType":168,"phases":169,"briefSummary":171,"conditions":172,"keywords":175,"overallStatus":180,"whyStopped":56,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},{"fullName":5,"class":6},"Tibet Autonomous Region People's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":56},[9,13,16,20],{"measure":10,"description":11,"timeFrame":12},"HAPE：Recovery","Patients are defined as recovered only when all of the following criteria are met simultaneously:\n\nResolution of clinical symptoms: complete relief of dyspnea (no shortness of breath at rest), disappearance of cough and expectoration, and resolution of chest tightness or chest pain.\n\nRestoration of normal physical signs: complete disappearance of lung crackles, resolution of cyanosis, and heart rate \\\u003C 100 beats per minute at rest.\n\nNormalization of physiological parameters: blood oxygen saturation (SpO₂) ≥ 90% above 3500 m altitude (≥ 88% above 4000 m altitude) and normal arterial blood gas analysis (if performed).\n\nImprovement on imaging studies: clear bilateral lung fields on chest X-ray, and resolution of alveolar exudation without significant effusion on chest CT.\n\nMeeting hospital discharge criteria: stable condition for more than 48 hours, recovery of self-care ability, and no requirement for continuous oxygen therapy.","From date of disease onset to achievement of recovery criteria ,assessed up to 36 months",{"measure":14,"description":15,"timeFrame":12},"HACE ：recovery","Patients are defined as recovered only when all of the following criteria are met simultaneously:\n\nRecovery of consciousness: Glasgow Coma Score (GCS) of 15, full restoration of orientation, and no signs of impaired consciousness.\n\nResolution of neurological symptoms: complete relief of headache, and disappearance of ataxia, nausea, vomiting, blurred vision, and other related symptoms.\n\nNormal neurological signs: disappearance of pathological reflexes, negative meningeal irritation signs, and normal cranial nerve function.\n\nImprovement on imaging: resolution of cerebral edema, no mass effect, and normal ventricular system on head CT or MRI.\n\nMeeting hospital discharge criteria: stable condition for more than 72 hours, recovery of activities of daily living, and no requirement for special monitoring.",{"measure":17,"description":18,"timeFrame":19},"Death","Death is defined as all-cause mortality occurring during hospitalization, or all-cause mortality within 30 days and 90 days after discharge.","From admission to discharge, or all-cause mortality within 30 days and 90 days after discharge.",{"measure":21,"description":22,"timeFrame":23},"Length of hospital stay","From the first day of admission to the day of discharge","The total duration from the first day of hospitalization to recovery and discharge, assessed up to 36 months",[25,29,32,36,39,42,46,49,52],{"measure":26,"description":27,"timeFrame":28},"HAPE：Improvement","Clinical symptoms improved by ≥50%, manifested as significant relief of dyspnea (no shortness of breath during mild activity), marked reduction in cough and expectoration, and alleviation of chest discomfort.\n\nPhysiological indicators improved, including a decrease in heart rate by ≥20 beats per minute from baseline, an increase in blood oxygen saturation by ≥5% compared with admission, and a respiratory rate \\\u003C 24 breaths per minute.\n\nImaging examinations showed a ≥50% reduction in pulmonary exudation on chest radiograph compared with admission, or a significant reduction in lesion extent on chest CT.","At discharge(assessed up to 5 days)",{"measure":30,"description":22,"timeFrame":31},"Length of ICU\u002FCCU stay","From date of the first day admimion in the ICU until the last day in the ICU, up to 48 weeks.",{"measure":33,"description":34,"timeFrame":35},"Duration of mechanical ventilation","Duration of mechanical ventilation, calculated in hours","From the date of the first day of mechanical ventilation until the last day of mechanical ventilation,up to 48 weeks.",{"measure":37,"description":38,"timeFrame":28},"Total hospitalization cost (CNY)","total expenses incurred during hospitalization",{"measure":40,"description":41,"timeFrame":28},"Time to independence from oxygen therapy (days)","Duration of oxygen therapy during hospitalization (days)",{"measure":43,"description":44,"timeFrame":45},"HAPE：incidence of complications","such as pulmonary embolism, pneumothorax, infection, etc","From date of admission until the date of discharge, and within 30 days and 90 days after discharge,up to 48 weeks.",{"measure":47,"description":48,"timeFrame":28},"HACE：improved","A patient is defined as having \"improved\" if meeting the following core criteria:\n\nImproved consciousness: Glasgow Coma Scale (GCS) score increased by ≥3 points from admission, partial recovery of orientation, and improved response to stimuli.\n\nImproved neurological symptoms: ≥50% reduction in headache severity (VAS score), significant improvement in ataxia, and decreased nausea and vomiting.\n\nImproved physiological indicators: heart rate decreased by ≥15 beats per minute from baseline, blood oxygen saturation increased by ≥5% compared with admission, and blood pressure controlled within the normal range.",{"measure":50,"description":51,"timeFrame":45},"HACE：Incidence of complications","such as seizures, intracranial infection, brain herniation, permanent neurological deficit",{"measure":53,"description":54,"timeFrame":55},"HACE：Modified Rankin Scale (mRS) score at 90 days","specifically categorized as: 0 (no symptoms),\n\n1. (no significant disability),\n2. (slight disability),\n3. (moderate disability),\n4. (moderately severe disability),\n5. (severe disability), and 6 (death).","From the first day of admission to 90 days thereafter",null,{"allocation":58,"interventionModel":59,"interventionModelDescription":56,"primaryPurpose":60,"observationalModel":56,"timePerspective":56,"maskingInfo":61},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":62,"maskingDescription":56,"whoMasked":56},"NONE",[64,68,71,74,77,80,83,86,89,92,99,104,107],{"label":65,"type":66,"description":67,"interventionNames":56},"HAPE： Calcium Channel Blocker (CCB) Group","NO_INTERVENTION","Calcium Channel Blocker (CCB) Group: Nifedipine sustained-release tablets: 30-60 mg\u002Fday, orally in 2-3 divided doses;",{"label":69,"type":66,"description":70,"interventionNames":56},"HAPE：Glucocorticoid Group","Dexamethasone: 8-16 mg\u002Fday, intravenous injection, tapering off after 3-5 days; Methylprednisolone: 40-80 mg\u002Fday, intravenous injection; Prednisone: 40-60 mg\u002Fday, oral administration;",{"label":72,"type":66,"description":73,"interventionNames":56},"HAPE：Diuretic Group","Furosemide: 40-80 mg\u002Fday, administered intravenously or orally; Spironolactone: 40-80 mg\u002Fday, administered orally; Note: Strictly monitor electrolytes and renal function.",{"label":75,"type":66,"description":76,"interventionNames":56},"HAPE：Theophylline Drugs Group","Aminophylline: 0.25-0.5g, intravenous drip, 1-2 times a day; Doxofylline: 200mg, intravenous drip, 2 times a day;",{"label":78,"type":66,"description":79,"interventionNames":56},"HAPE：Combined Treatment Group","CCB + Glucocorticoid: Nifedipine + Dexamethasone; Glucocorticoid + Diuretic: Dexamethasone + Furosemide; Triple Therapy: CCB + Glucocorticoid + Diuretic.",{"label":81,"type":66,"description":82,"interventionNames":56},"HACE：Osmotic Diuretic Group","0.5-1.0 g\u002Fkg, rapid intravenous infusion, once every 6-8 hours; Hypertonic saline: 3% sodium chloride solution, 250 ml intravenous infusion. Monitoring indicators: intracranial pressure, blood osmotic pressure, renal function.",{"label":84,"type":66,"description":85,"interventionNames":56},"HACE：Intensive Glucocorticoid Treatment Group","High-dose dexamethasone: 16-32 mg\u002Fday, intravenously; Methylprednisolone pulse therapy: 500-1000 mg\u002Fday for 3 days, followed by dosage tapering. Treatment course: 7-10 days with gradual dose reduction.",{"label":87,"type":66,"description":88,"interventionNames":56},"HACE：Combined Intracranial Pressure-Reducing Treatment Group","Mannitol + Glucocorticoid: Mannitol 0.5 g\u002Fkg + Dexamethasone 16 mg\u002Fday; Hypertonic saline + Glucocorticoid: 3% NaCl + Methylprednisolone; Triple therapy: Mannitol + Glucocorticoid + Diuretic.",{"label":90,"type":66,"description":91,"interventionNames":56},"HACE：Other Adjuvant Drug Group","Furosemide: 20-40 mg\u002Fday to reduce cerebral edema; Albumin: 25% albumin 50 ml to increase plasma colloid osmotic pressure; Sodium aescinate: 20-40 mg\u002Fday to improve vascular permeability.",{"label":93,"type":94,"description":95,"interventionNames":96},"Multicenter Study of HAPE：Traditional Classic Treatment Group","EXPERIMENTAL","Oxygen inhalation plus CCB or aminophylline",[97,98],"Device: Multicenter study of HAPE：CPAP or BiPAP Group","Drug: Multicenter study of HAPE group：NO Group",{"label":100,"type":94,"description":101,"interventionNames":102},"Protocol for Proteomics and Peptidomics Study of HAPE：Control Group","40 healthy individuals who are either migrant residents or indigenous residents at high altitude. Age, gender, and residential altitude were strictly matched. Peripheral venous blood samples were collected during the same period.",[103],"Other: Protocol for Proteomics and Peptidomics Study of HAPE：Case Group",{"label":105,"type":66,"description":106,"interventionNames":56},"HAPE Database","To establish a High-Altitude Pulmonary Edema (HAPE) Database (≥1000 cases) through a multicenter retrospective study.",{"label":108,"type":66,"description":109,"interventionNames":56},"HACE Database","To establish a High-Altitude Pulmonary Edema (HACE) Database (≥400 cases) through a multicenter retrospective study.",[111,116,121],{"type":112,"name":113,"description":114,"armGroupLabels":115,"otherNames":56},"DEVICE","Multicenter study of HAPE：CPAP or BiPAP Group","Traditional treatment plus CPAP or BiPAP",[93],{"type":117,"name":118,"description":119,"armGroupLabels":120,"otherNames":56},"DRUG","Multicenter study of HAPE group：NO Group","Traditional treatment plus inhaled nitric oxide therapy (20-40 ppm, continuous administration for 12-24 hours)",[93],{"type":6,"name":122,"description":123,"armGroupLabels":124,"otherNames":56},"Protocol for Proteomics and Peptidomics Study of HAPE：Case Group","40 patients clinically diagnosed with HAPE. Peripheral venous blood samples were collected during the acute onset stage and prior to any effective intervention.",[100],[126],{"name":127,"role":128,"phone":129,"phoneExt":56,"email":130},"Gesang Luobu, MD","CONTACT","8618108912487","kelsangnorbu@hotmail.com",[132],{"facility":133,"status":56,"city":134,"state":135,"zip":136,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":144,"contacts":145},"Xizang Autonomous Region People's Hospital","Lhasa","Tibet","850000","China","CN",{"type":140,"coordinates":141},"Point",[142,143],91.1,29.65,{"lat":143,"lon":142},[146],{"name":147,"role":128,"phone":148,"phoneExt":56,"email":149},"li hui Yang","13638992795","1640794768@qq.com",{"type":151,"investigatorFullName":152,"investigatorTitle":153,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"PRINCIPAL_INVESTIGATOR","Gesang Lobb","First-Class Chief Physician, Department of Cardiovascular Medicine","100643117",false,"NCT07639931","Key Diagnostic & Therapeutic Technologies for Severe Acute High Altitude Disease (SAHAD): Integration and Application","Integration and Application Demonstration of Key Diagnosis and Treatment Technologies for Severe Acute High Altitude Disease","SAHAD","Inclusion Criteria:\n\n1. Meeting the diagnostic criteria for severe acute mountain sickness (including high-altitude pulmonary edema \\[HAPE\\] and high-altitude cerebral edema \\[HACE\\]).\n2. Aged 18 to 75 years.\n3. Rapid ascent to an altitude above 2500 m within 72 hours prior to onset.\n\nExclusion Criteria:\n\n1. History of severe cardiopulmonary diseases.\n2. Pregnant women, patients with psychiatric disorders, inability to cooperate with treatment or follow-up, and patients with an expected survival of less than 6 months.\n3. Patients with malignant tumors, severe hepatic or renal insufficiency, or immune system diseases requiring immunosuppressive therapy.",true,"ALL","18 Years","75 Years",{"count":166,"type":167},3035,"ESTIMATED","INTERVENTIONAL",[170],"NA","This study aims to establish a key technical system for the diagnosis and treatment of severe acute mountain sickness based on real-world clinical data in Xizang, develop standardized diagnosis and treatment protocols and an intelligent early warning model, validate its efficacy through multicenter studies, and innovate diagnostic and therapeutic technologies. It will achieve early identification, precise diagnosis, standardized treatment, and intelligent warning of severe acute mountain sickness, comprehensively improving its prevention, control and treatment success rate.",[173,174],"Severe High Altitude Pulmonary Edema","Severe High Altitude Cerebral Edema",[176,177,178,179],"High altitude","Key Diagnostic","Therapeutic Technologies","Severe Acute High Altitude Disease (SAHAD)","NOT_YET_RECRUITING","2026-06-07",{"date":183,"type":184},"2026-06-10","ACTUAL",{"date":186,"type":167},"2026-07-01",{"date":188,"type":167},"2028-12-31",{"name":5,"class":6},1]