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Key Diagnostic & Therapeutic Technologies for Severe Acute High Altitude Disease (SAHAD): Integration and Application (SAHAD)

7 juni 2026 bijgewerkt door: Gesang Lobb, Tibet Autonomous Region People's Hospital

Integration and Application Demonstration of Key Diagnosis and Treatment Technologies for Severe Acute High Altitude Disease

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

3035

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Tibet
      • Lhasa, Tibet, China, 850000
        • Xizang Autonomous Region People's Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  1. Meeting the diagnostic criteria for severe acute mountain sickness (including high-altitude pulmonary edema [HAPE] and high-altitude cerebral edema [HACE]).
  2. Aged 18 to 75 years.
  3. Rapid ascent to an altitude above 2500 m within 72 hours prior to onset.

Exclusion Criteria:

  1. History of severe cardiopulmonary diseases.
  2. 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.
  3. Patients with malignant tumors, severe hepatic or renal insufficiency, or immune system diseases requiring immunosuppressive therapy.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: HAPE： Calcium Channel Blocker (CCB) Group
Calcium Channel Blocker (CCB) Group: Nifedipine sustained-release tablets: 30-60 mg/day, orally in 2-3 divided doses;
Geen tussenkomst: HAPE：Glucocorticoid Group
Dexamethasone: 8-16 mg/day, intravenous injection, tapering off after 3-5 days; Methylprednisolone: 40-80 mg/day, intravenous injection; Prednisone: 40-60 mg/day, oral administration;
Geen tussenkomst: HAPE：Diuretic Group
Furosemide: 40-80 mg/day, administered intravenously or orally; Spironolactone: 40-80 mg/day, administered orally; Note: Strictly monitor electrolytes and renal function.
Geen tussenkomst: HAPE：Theophylline Drugs Group
Aminophylline: 0.25-0.5g, intravenous drip, 1-2 times a day; Doxofylline: 200mg, intravenous drip, 2 times a day;
Geen tussenkomst: HAPE：Combined Treatment Group
CCB + Glucocorticoid: Nifedipine + Dexamethasone; Glucocorticoid + Diuretic: Dexamethasone + Furosemide; Triple Therapy: CCB + Glucocorticoid + Diuretic.
Geen tussenkomst: HACE：Osmotic Diuretic Group
0.5-1.0 g/kg, 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.
Geen tussenkomst: HACE：Intensive Glucocorticoid Treatment Group
High-dose dexamethasone: 16-32 mg/day, intravenously; Methylprednisolone pulse therapy: 500-1000 mg/day for 3 days, followed by dosage tapering. Treatment course: 7-10 days with gradual dose reduction.
Geen tussenkomst: HACE：Combined Intracranial Pressure-Reducing Treatment Group
Mannitol + Glucocorticoid: Mannitol 0.5 g/kg + Dexamethasone 16 mg/day; Hypertonic saline + Glucocorticoid: 3% NaCl + Methylprednisolone; Triple therapy: Mannitol + Glucocorticoid + Diuretic.
Geen tussenkomst: HACE：Other Adjuvant Drug Group
Furosemide: 20-40 mg/day to reduce cerebral edema; Albumin: 25% albumin 50 ml to increase plasma colloid osmotic pressure; Sodium aescinate: 20-40 mg/day to improve vascular permeability.
Experimenteel: Multicenter Study of HAPE：Traditional Classic Treatment Group
Oxygen inhalation plus CCB or aminophylline
Apparaat: Multicenter study of HAPE：CPAP or BiPAP Group
Traditional treatment plus CPAP or BiPAP
Geneesmiddel: Multicenter study of HAPE group：NO Group
Traditional treatment plus inhaled nitric oxide therapy (20-40 ppm, continuous administration for 12-24 hours)
Experimenteel: 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.
Ander: 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.
Geen tussenkomst: HAPE Database
To establish a High-Altitude Pulmonary Edema (HAPE) Database (≥1000 cases) through a multicenter retrospective study.
Geen tussenkomst: HACE Database
To establish a High-Altitude Pulmonary Edema (HACE) Database (≥400 cases) through a multicenter retrospective study.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
HAPE：Recovery
Tijdsspanne: From date of disease onset to achievement of recovery criteria ,assessed up to 36 months

Patients are defined as recovered only when all of the following criteria are met simultaneously:

Resolution 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.

Restoration of normal physical signs: complete disappearance of lung crackles, resolution of cyanosis, and heart rate < 100 beats per minute at rest.

Normalization 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).

Improvement on imaging studies: clear bilateral lung fields on chest X-ray, and resolution of alveolar exudation without significant effusion on chest CT.

Meeting 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
HACE ：recovery
Tijdsspanne: From date of disease onset to achievement of recovery criteria ,assessed up to 36 months

Patients are defined as recovered only when all of the following criteria are met simultaneously:

Recovery of consciousness: Glasgow Coma Score (GCS) of 15, full restoration of orientation, and no signs of impaired consciousness.

Resolution of neurological symptoms: complete relief of headache, and disappearance of ataxia, nausea, vomiting, blurred vision, and other related symptoms.

Normal neurological signs: disappearance of pathological reflexes, negative meningeal irritation signs, and normal cranial nerve function.

Improvement on imaging: resolution of cerebral edema, no mass effect, and normal ventricular system on head CT or MRI.

Meeting hospital discharge criteria: stable condition for more than 72 hours, recovery of activities of daily living, and no requirement for special monitoring.
From date of disease onset to achievement of recovery criteria ,assessed up to 36 months
Death
Tijdsspanne: From admission to discharge, or all-cause mortality within 30 days and 90 days after discharge.
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.
Length of hospital stay
Tijdsspanne: The total duration from the first day of hospitalization to recovery and discharge, assessed up to 36 months
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
HAPE：Improvement
Tijdsspanne: At discharge(assessed up to 5 days)

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.

Physiological 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 < 24 breaths per minute.

Imaging 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)
Length of ICU/CCU stay
Tijdsspanne: From date of the first day admimion in the ICU until the last day in the ICU, up to 48 weeks.
From the first day of admission to the day of discharge
From date of the first day admimion in the ICU until the last day in the ICU, up to 48 weeks.
Duration of mechanical ventilation
Tijdsspanne: From the date of the first day of mechanical ventilation until the last day of mechanical ventilation,up to 48 weeks.
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.
Total hospitalization cost (CNY)
Tijdsspanne: At discharge(assessed up to 5 days)
total expenses incurred during hospitalization
At discharge(assessed up to 5 days)
Time to independence from oxygen therapy (days)
Tijdsspanne: At discharge(assessed up to 5 days)
Duration of oxygen therapy during hospitalization (days)
At discharge(assessed up to 5 days)
HAPE：incidence of complications
Tijdsspanne: From date of admission until the date of discharge, and within 30 days and 90 days after discharge,up to 48 weeks.
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.
HACE：improved
Tijdsspanne: At discharge(assessed up to 5 days)

A patient is defined as having "improved" if meeting the following core criteria:

Improved consciousness: Glasgow Coma Scale (GCS) score increased by ≥3 points from admission, partial recovery of orientation, and improved response to stimuli.

Improved neurological symptoms: ≥50% reduction in headache severity (VAS score), significant improvement in ataxia, and decreased nausea and vomiting.

Improved 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.
At discharge(assessed up to 5 days)
HACE：Incidence of complications
Tijdsspanne: From date of admission until the date of discharge, and within 30 days and 90 days after discharge,up to 48 weeks.
such as seizures, intracranial infection, brain herniation, permanent neurological deficit
From date of admission until the date of discharge, and within 30 days and 90 days after discharge,up to 48 weeks.
HACE：Modified Rankin Scale (mRS) score at 90 days
Tijdsspanne: From the first day of admission to 90 days thereafter

specifically categorized as: 0 (no symptoms),

  1. (no significant disability),
  2. (slight disability),
  3. (moderate disability),
  4. (moderately severe disability),
  5. (severe disability), and 6 (death).
From the first day of admission to 90 days thereafter

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tibet Autonomous Region People's Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

20 december 2028

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

14 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 juni 2026

Eerst geplaatst (Werkelijk)

10 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

7 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ME-TBHP-25-090

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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