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

2026年6月7日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

3035

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Tibet
      • Lhasa、Tibet、中国、850000
        • Xizang Autonomous Region People's Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：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;
无干预：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;
无干预：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.
无干预：HAPE：Theophylline Drugs Group
Aminophylline: 0.25-0.5g, intravenous drip, 1-2 times a day; Doxofylline: 200mg, intravenous drip, 2 times a day;
无干预：HAPE：Combined Treatment Group
CCB + Glucocorticoid: Nifedipine + Dexamethasone; Glucocorticoid + Diuretic: Dexamethasone + Furosemide; Triple Therapy: CCB + Glucocorticoid + Diuretic.
无干预：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.
无干预：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.
无干预：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.
无干预：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.
实验性的：Multicenter Study of HAPE：Traditional Classic Treatment Group
Oxygen inhalation plus CCB or aminophylline
设备：Multicenter study of HAPE：CPAP or BiPAP Group
Traditional treatment plus CPAP or BiPAP
药品：Multicenter study of HAPE group：NO Group
Traditional treatment plus inhaled nitric oxide therapy (20-40 ppm, continuous administration for 12-24 hours)
实验性的：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.
其他：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.
无干预：HAPE Database
To establish a High-Altitude Pulmonary Edema (HAPE) Database (≥1000 cases) through a multicenter retrospective study.
无干预：HACE Database
To establish a High-Altitude Pulmonary Edema (HACE) Database (≥400 cases) through a multicenter retrospective study.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
HAPE：Recovery
大体时间：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
大体时间：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
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
HAPE：Improvement
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Tibet Autonomous Region People's Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2028年12月20日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年5月14日

首先提交符合 QC 标准的

2026年6月7日

首次发布 (实际的)

2026年6月10日

研究记录更新

最后更新发布 (实际的)

2026年6月10日

上次提交的符合 QC 标准的更新

2026年6月7日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ME-TBHP-25-090

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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