Severe High Altitude Pulmonary EdemaSAHADNCT07639931

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

A study testing Multicenter study of HAPE：CPAP or BiPAP Group, Multicenter study of HAPE group：NO Group and Protocol for Proteomics and Peptidomics Study of HAPE：Case Group in people with Severe High Altitude Pulmonary Edema and Severe High Altitude Cerebral Edema, run by Tibet Autonomous Region People's Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Severe High Altitude Pulmonary Edema, Severe High Altitude Cerebral Edema
What is being tested?: Multicenter study of HAPE：CPAP or BiPAP Group, Multicenter study of HAPE group：NO Group and Protocol for Proteomics and Peptidomics Study of HAPE：Case Group
Type of treatment: Pill or oral medicine, Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,035 participants
Where: 1 siteChina
Study dates: 1 Jul 2026to 31 Dec 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gesang Luobu, MD contact

8618108912487

kelsangnorbu@hotmail.com

China1 site

Xizang Autonomous Region People's Hospital
Lhasa, Tibet, 850000
li hui Yang, 13638992795, 1640794768@qq.com

Other trials in China

About this study

Official title: 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.

Conditions: Severe High Altitude Pulmonary Edema, Severe High Altitude Cerebral Edema
Being tested: Multicenter study of HAPE：CPAP or BiPAP Group, Multicenter study of HAPE group：NO Group, Protocol for Proteomics and Peptidomics Study of HAPE：Case Group
Keywords: High altitude, Key Diagnostic, Therapeutic Technologies, Severe Acute High Altitude Disease (SAHAD)
Medical subject headings: Altitude Sickness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multicenter study of HAPE：CPAP or BiPAP GroupDevice
Traditional treatment plus CPAP or BiPAP
Multicenter study of HAPE group：NO GroupDrug
Traditional treatment plus inhaled nitric oxide therapy (20-40 ppm, continuous administration for 12-24 hours)
Protocol for Proteomics and Peptidomics Study of HAPE：Case GroupOther
40 patients clinically diagnosed with HAPE. Peripheral venous blood samples were collected during the acute onset stage and prior to any effective intervention.

Study groups in NCT07639931
Study group	Role	What they receive
HAPE： Calcium Channel Blocker (CCB) Group	No intervention	Calcium Channel Blocker (CCB) Group: Nifedipine sustained-release tablets: 30-60 mg/day, orally in 2-3 divided doses;
HAPE：Glucocorticoid Group	No intervention	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;
HAPE：Diuretic Group	No intervention	Furosemide: 40-80 mg/day, administered intravenously or orally; Spironolactone: 40-80 mg/day, administered orally; Note: Strictly monitor electrolytes and renal function.
HAPE：Theophylline Drugs Group	No intervention	Aminophylline: 0.25-0.5g, intravenous drip, 1-2 times a day; Doxofylline: 200mg, intravenous drip, 2 times a day;
HAPE：Combined Treatment Group	No intervention	CCB + Glucocorticoid: Nifedipine + Dexamethasone; Glucocorticoid + Diuretic: Dexamethasone + Furosemide; Triple Therapy: CCB + Glucocorticoid + Diuretic.
HACE：Osmotic Diuretic Group	No intervention	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.
HACE：Intensive Glucocorticoid Treatment Group	No intervention	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.
HACE：Combined Intracranial Pressure-Reducing Treatment Group	No intervention	Mannitol + Glucocorticoid: Mannitol 0.5 g/kg + Dexamethasone 16 mg/day; Hypertonic saline + Glucocorticoid: 3% NaCl + Methylprednisolone; Triple therapy: Mannitol + Glucocorticoid + Diuretic.
HACE：Other Adjuvant Drug Group	No intervention	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.
Multicenter Study of HAPE：Traditional Classic Treatment Group	Experimental	Oxygen inhalation plus CCB or aminophylline Receives: Device: Multicenter study of HAPE：CPAP or BiPAP Group; Drug: Multicenter study of HAPE group：NO Group
Protocol for Proteomics and Peptidomics Study of HAPE：Control Group	Experimental	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. Receives: Other: Protocol for Proteomics and Peptidomics Study of HAPE：Case Group
HAPE Database	No intervention	To establish a High-Altitude Pulmonary Edema (HAPE) Database (≥1000 cases) through a multicenter retrospective study.
HACE Database	No intervention	To establish a High-Altitude Pulmonary Edema (HACE) Database (≥400 cases) through a multicenter retrospective study.

What is being measured

The primary outcome is the main question the study is designed to answer.

HAPE：Recovery
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.
Measured: From date of disease onset to achievement of recovery criteria ,assessed up to 36 months
HACE ：recovery
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.
Measured: From date of disease onset to achievement of recovery criteria ,assessed up to 36 months
Death
Death is defined as all-cause mortality occurring during hospitalization, or all-cause mortality within 30 days and 90 days after discharge.
Measured: From admission to discharge, or all-cause mortality within 30 days and 90 days after discharge.
Length of hospital stay
From the first day of admission to the day of discharge
Measured: The total duration from the first day of hospitalization to recovery and discharge, assessed up to 36 months

Secondary outcomes (9)

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.
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.
Measured: At discharge(assessed up to 5 days)
Length of ICU/CCU stay
From the first day of admission to the day of discharge
Measured: 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
Duration of mechanical ventilation, calculated in hours
Measured: 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)
total expenses incurred during hospitalization
Measured: At discharge(assessed up to 5 days)
Time to independence from oxygen therapy (days)
Duration of oxygen therapy during hospitalization (days)
Measured: At discharge(assessed up to 5 days)
HAPE：incidence of complications
such as pulmonary embolism, pneumothorax, infection, etc
Measured: From date of admission until the date of discharge, and within 30 days and 90 days after discharge,up to 48 weeks.
HACE：improved
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.
Measured: At discharge(assessed up to 5 days)
HACE：Incidence of complications
such as seizures, intracranial infection, brain herniation, permanent neurological deficit
Measured: 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
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).
Measured: From the first day of admission to 90 days thereafter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202631 Dec 2028

First posted10 Jun 2026
Study start1 Jul 2026 (estimated)
Primary completion20 Dec 2028 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Severe High Altitude Pulmonary EdemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 3,035 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07639931
Sponsor's protocol ID: ME-TBHP-25-090
Acronym: SAHAD
Status last verified: Jun 2026
First submitted: 14 May 2026
Last updated: 10 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Integration and Application Demonstration of Key Diagnosis and Treatment Technologies for Severe Acute High Altitude Disease
ClinicalTrials.gov ID: NCT07639931
Acronym / sponsor ID: SAHAD / ME-TBHP-25-090
Conditions: Severe High Altitude Pulmonary Edema, Severe High Altitude Cerebral Edema
Keywords: High altitude, Key Diagnostic, Therapeutic Technologies, Severe Acute High Altitude Disease (SAHAD)
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 3,035 participants (estimated)
Lead sponsor: Tibet Autonomous Region People's HospitalUniversity, hospital or other
Study start: 1 Jul 2026 (estimated)
Primary completion: 20 Dec 2028 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 10 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 13

Arm	Type	Receives
HAPE： Calcium Channel Blocker (CCB) Group	No intervention	–Calcium Channel Blocker (CCB) Group: Nifedipine sustained-release tablets: 30-60 mg/day, orally in 2-3 divided doses;
HAPE：Glucocorticoid Group	No intervention	–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;
HAPE：Diuretic Group	No intervention	–Furosemide: 40-80 mg/day, administered intravenously or orally; Spironolactone: 40-80 mg/day, administered orally; Note: Strictly monitor electrolytes and renal function.
HAPE：Theophylline Drugs Group	No intervention	–Aminophylline: 0.25-0.5g, intravenous drip, 1-2 times a day; Doxofylline: 200mg, intravenous drip, 2 times a day;
HAPE：Combined Treatment Group	No intervention	–CCB + Glucocorticoid: Nifedipine + Dexamethasone; Glucocorticoid + Diuretic: Dexamethasone + Furosemide; Triple Therapy: CCB + Glucocorticoid + Diuretic.
HACE：Osmotic Diuretic Group	No intervention	–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.
HACE：Intensive Glucocorticoid Treatment Group	No intervention	–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.
HACE：Combined Intracranial Pressure-Reducing Treatment Group	No intervention	–Mannitol + Glucocorticoid: Mannitol 0.5 g/kg + Dexamethasone 16 mg/day; Hypertonic saline + Glucocorticoid: 3% NaCl + Methylprednisolone; Triple therapy: Mannitol + Glucocorticoid + Diuretic.
HACE：Other Adjuvant Drug Group	No intervention	–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.
Multicenter Study of HAPE：Traditional Classic Treatment Group	Experimental	Device: Multicenter study of HAPE：CPAP or BiPAP Group, Drug: Multicenter study of HAPE group：NO GroupOxygen inhalation plus CCB or aminophylline
Protocol for Proteomics and Peptidomics Study of HAPE：Control Group	Experimental	Other: Protocol for Proteomics and Peptidomics Study of HAPE：Case Group40 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.
HAPE Database	No intervention	–To establish a High-Altitude Pulmonary Edema (HAPE) Database (≥1000 cases) through a multicenter retrospective study.
HACE Database	No intervention	–To establish a High-Altitude Pulmonary Edema (HACE) Database (≥400 cases) through a multicenter retrospective study.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Multicenter study of HAPE：CPAP or BiPAP GroupTraditional treatment plus CPAP or BiPAP	Device	Multicenter Study of HAPE：Traditional Classic Treatment Group
Multicenter study of HAPE group：NO GroupTraditional treatment plus inhaled nitric oxide therapy (20-40 ppm, continuous administration for 12-24 hours)	Drug	Multicenter Study of HAPE：Traditional Classic Treatment Group
Protocol for Proteomics and Peptidomics Study of HAPE：Case Group40 patients clinically diagnosed with HAPE. Peripheral venous blood samples were collected during the acute onset stage and prior to any effective intervention.	Other	Protocol for Proteomics and Peptidomics Study of HAPE：Control Group

Primary outcome

HAPE：Recovery
Time frame: 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.
HACE ：recovery
Time frame: 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.
Death
Time frame: 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.
Length of hospital stay
Time frame: 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

9 secondary outcomes

HAPE：Improvement
Time frame: At discharge(assessed up to 5 days)
Length of ICU/CCU stay
Time frame: 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
Time frame: 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)
Time frame: At discharge(assessed up to 5 days)
Time to independence from oxygen therapy (days)
Time frame: At discharge(assessed up to 5 days)
HAPE：incidence of complications
Time frame: From date of admission until the date of discharge, and within 30 days and 90 days after discharge,up to 48 weeks.
HACE：improved
Time frame: At discharge(assessed up to 5 days)
HACE：Incidence of complications
Time frame: 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
Time frame: From the first day of admission to 90 days thereafter

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Gesang Luobu, MD contact

8618108912487

kelsangnorbu@hotmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gesang Luobu, MD (8618108912487, kelsangnorbu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HAPE：Recovery (time frame: From date of disease onset to achievement of recovery criteria ,assessed up to 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07639931.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.