Key Diagnostic & Therapeutic Technologies for Severe Acute High Altitude Disease (SAHAD): Integration and Application (SAHAD)
Integration and Application Demonstration of Key Diagnosis and Treatment Technologies for Severe Acute High Altitude Disease
Studienübersicht
Status
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Gesang Luobu, MD
- Telefonnummer: 8618108912487
- E-Mail: kelsangnorbu@hotmail.com
Studienorte
-
-
Tibet
-
Lhasa, Tibet, China, 850000
- Xizang Autonomous Region People's Hospital
-
Kontakt:
- li hui Yang
- Telefonnummer: 13638992795
- E-Mail: 1640794768@qq.com
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Meeting the diagnostic criteria for severe acute mountain sickness (including high-altitude pulmonary edema [HAPE] and high-altitude cerebral edema [HACE]).
- Aged 18 to 75 years.
- Rapid ascent to an altitude above 2500 m within 72 hours prior to onset.
Exclusion Criteria:
- History of severe cardiopulmonary diseases.
- 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.
- Patients with malignant tumors, severe hepatic or renal insufficiency, or immune system diseases requiring immunosuppressive therapy.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: 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;
|
|
|
Kein Eingriff: 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;
|
|
|
Kein Eingriff: 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.
|
|
|
Kein Eingriff: HAPE：Theophylline Drugs Group
Aminophylline: 0.25-0.5g,
intravenous drip, 1-2 times a day; Doxofylline: 200mg, intravenous drip, 2 times a day;
|
|
|
Kein Eingriff: HAPE：Combined Treatment Group
CCB + Glucocorticoid: Nifedipine + Dexamethasone; Glucocorticoid + Diuretic: Dexamethasone + Furosemide; Triple Therapy: CCB + Glucocorticoid + Diuretic.
|
|
|
Kein Eingriff: 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.
|
|
|
Kein Eingriff: 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.
|
|
|
Kein Eingriff: 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.
|
|
|
Kein Eingriff: 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.
|
|
|
Experimental: Multicenter Study of HAPE：Traditional Classic Treatment Group
Oxygen inhalation plus CCB or aminophylline
|
Traditional treatment plus CPAP or BiPAP
Traditional treatment plus inhaled nitric oxide therapy (20-40 ppm, continuous administration for 12-24 hours)
|
|
Experimental: 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.
|
40 patients clinically diagnosed with HAPE.
Peripheral venous blood samples were collected during the acute onset stage and prior to any effective intervention.
|
|
Kein Eingriff: HAPE Database
To establish a High-Altitude Pulmonary Edema (HAPE) Database (≥1000 cases) through a multicenter retrospective study.
|
|
|
Kein Eingriff: HACE Database
To establish a High-Altitude Pulmonary Edema (HACE) Database (≥400 cases) through a multicenter retrospective study.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
HAPE：Recovery
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
HAPE：Improvement
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: From the first day of admission to 90 days thereafter
|
specifically categorized as: 0 (no symptoms),
|
From the first day of admission to 90 days thereafter
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ME-TBHP-25-090
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .