Acute Mountain SicknessPhase 4NCT05023941
Optimization Strategy for the Prevention of AMS by RIPC Combined With Acetazolamide
A Phase 4 study testing Acetazolamide, Doctormate® (twice daily for 6 days) and Doctormate® (forth daily for 3 days) in people with Acute Mountain Sickness, run by Ji Xunming,MD,PhD at 1 site in China.
Trial summary
The primary objective of the study will be to determine whether rapid remote limb ischemic preconditioning (RIPC) combined with acetazolamide can further reduce the incidence of acute mountain sickness (AMS) during the 6-hour hypoxic chamber. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness
- What is being tested?
- Acetazolamide, Doctormate® (twice daily for 6 days) and Doctormate® (forth daily for 3 days)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 30 Aug 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- People who live in plain areas all year round and have not been to an altitude of 1500 meters or more in the past 30 days;
- Sign the informed consent form voluntarily.
Who cannot join
- Chronic physical or mental diseases, including hypertension, diabetes, coronary heart disease, cerebrovascular disease, chronic obstructive pulmonary disease, migraine, anxiety, depression, insomnia, etc.;
- The female is pregnant or in the period of preparing for pregnancy or breast-feeding;
- Have a history of smoking;
- Have a history of thrombosis in the upper limbs;
- Severe damage to local soft tissues of upper limbs, fractures, etc.;
- Allergic to sulfa;
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- Are taking one or more drugs;
- Past laboratory tests suggest hypokalemia, hyponatremia, or liver and kidney damage;
- Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: Optimization Strategy for the Prevention of Acute Mountain Sickness by Remote Ischemic Preconditioning Combined With Acetazolamide
The primary objective of the study will be to determine whether rapid remote limb ischemic preconditioning (RIPC) combined with acetazolamide can further reduce the incidence of acute mountain sickness (AMS) during the 6-hour hypoxic chamber.
Read the detailed description
The current measures to prevent acute mountain sickness (AMS) mainly include drug prevention and non-drug prevention. Acetazolamide is a drug approved by the U.S. FDA for the prevention and treatment of AMS. Remote limb ischemic preconditioning (RIPC) can also reduce the incidence of AMS as a non-durg method, with a strategy of 2 times/day training for 1 week reducing the incidence of AMS in 6 hours from 40% to 30%. The objective of this study is to determine whether rapid RIPC training combined with acetazolamide can further reduce the incidence of AMS. In this study, subjects will be divided into 5 groups: medicine group (acetazolamid 125mg bid, 2 days before entering the hypoxic room), RIPC group (RIPC training twice daily, 6 days before entering the hypoxic room), rapid RIPC group (RIPC training forth daily, 3 days before entering the hypoxic room), combined group (rapid RIPC training plus acetazolamide) and controlled group. RIPC training, completed by Renqiao Remote Ischemic Conditioning Device (Doctormate®), will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. After the intervention, subjects will be exposed to 4500m altitude in a normobaric hypoxic chamber for 6 hours. The incidence of AMS and other data will be compared between groups.
- Conditions
- Acute Mountain Sickness
- Being tested
- Acetazolamide, Doctormate® (twice daily for 6 days), Doctormate® (forth daily for 3 days)
- Keywords
- Acute Mountain Sickness, Acetazolamide, Remote Ischemic Preconditioning
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Start orally take acetazolamide 125mg twice daily, 2 days before entering the hypoxic chamber. Subjects will enter the hypoxic room at 9am on the third day. At that time, the subject should have taken the drug 5 times.
Doctormate® (twice daily for 6 days)Device
Start RIPC training twice daily, 6 days before entering the hypoxic chamber. RIPC will be induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®). Each training will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. Subjects will enter the hypoxic room at 9am on the seventh day. At that time, the subject should have finished 13 times of RIPC training.
Doctormate® (forth daily for 3 days)Device
Start RIPC training forth daily, 3 days before entering the hypoxic chamber. RIPC will be induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®). Each training will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. Subjects will enter the hypoxic room at 9am on the forth day. At that time, the subject should have finished 13 times of RIPC training.
| Study group | Role | What they receive |
|---|---|---|
| Medicine Group | Active comparator | Start orally take Acetazolamide 2 days before entering the hypoxic room. Receives: Drug: Acetazolamide |
| RIPC Group | Active comparator | Start RIPC training twice daily, 6 days before entering the hypoxic room. Receives: Device: Doctormate® (twice daily for 6 days) |
| Rapid RIPC Group | Experimental | Start RIPC training forth daily, 3 days before entering the hypoxic room. Receives: Device: Doctormate® (forth daily for 3 days) |
| Combined Group | Experimental | Medicine + Rapid RIPC Receives: Drug: Acetazolamide; Device: Doctormate® (forth daily for 3 days) |
| Control Group | No intervention | Subjects do not receive specific interventions before entering the hypoxic room. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of acute mountain sickness.
The diagnosis of acute mountain sickness is based on '2018 Lake Louise Acute Mountain Sickness Score' , 'Acute Mountain Sickness-Cerebral Scores',etc. All subjects should finish the questionnaires to evaluate the total incidence.
Measured: 6 hours after entering the hypoxic room.
The severity of acute mountain sickness.
The diagnosis of acute mountain sickness is based on '2018 Lake Louise Acute Mountain Sickness Score' , 'Acute Mountain Sickness-Cerebral Scores',etc. All subjects should finish the questionnaires to evaluate the total incidence.
Measured: 6 hours after entering the hypoxic room.
Fingre pulse oximetry of the subjects.
Fingre pulse oximetry using pocket pulse oximeters will be noted.
Measured: 6 hours after entering the hypoxic room.
Secondary outcomes (3)
Blood pressure of the subjects.
Including systolic and diastolic pressure.
Measured: 6 hours after entering the hypoxic room.
Heart rate of the subjects.
Measured: 6 hours after entering the hypoxic room.
Respiratory rate of the subjects.
Measured: 6 hours after entering the hypoxic room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Dec 2021
- Primary completion22 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Mountain SicknessStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ji Xunming,MD,PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ji Xunming,MD,PhD, Capital Medical University
- Investigators
- Xunming Ji, MD.PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023941
- Sponsor's protocol ID
- RIPC-Acet-AMS
- Status last verified
- Sep 2022
- First submitted
- 15 Aug 2021
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu M, Jiao X, Li R, Li J, Wang L, Wang L, Wang Y, Lv C, Huang D, Wei R, Wang L, Ji X, Guo X. Effects of acetazolamide combined with remote ischemic preconditioning on risk of acute mountain sickness: a randomized clinical trial. BMC Med. 2024 Jan 2;22(1):4. doi: 10.1186/s12916-023-03209-7.
PubMed 38166913
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization Strategy for the Prevention of Acute Mountain Sickness by Remote Ischemic Preconditioning Combined With Acetazolamide
- ClinicalTrials.gov ID
- NCT05023941
- Acronym / sponsor ID
- RIPC-Acet-AMS
- Conditions
- Acute Mountain Sickness
- Keywords
- Acute Mountain Sickness, Acetazolamide, Remote Ischemic Preconditioning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Ji Xunming,MD,PhDUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 27 Aug 2021 (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.
The primary objective of the study will be to determine whether rapid remote limb ischemic preconditioning (RIPC) combined with acetazolamide can further reduce the incidence of acute mountain sickness (AMS) during the 6-hour hypoxic chamber.
Detailed description
The current measures to prevent acute mountain sickness (AMS) mainly include drug prevention and non-drug prevention. Acetazolamide is a drug approved by the U.S. FDA for the prevention and treatment of AMS. Remote limb ischemic preconditioning (RIPC) can also reduce the incidence of AMS as a non-durg method, with a strategy of 2 times/day training for 1 week reducing the incidence of AMS in 6 hours from 40% to 30%. The objective of this study is to determine whether rapid RIPC training combined with acetazolamide can further reduce the incidence of AMS. In this study, subjects will be divided into 5 groups: medicine group (acetazolamid 125mg bid, 2 days before entering the hypoxic room), RIPC group (RIPC training twice daily, 6 days before entering the hypoxic room), rapid RIPC group (RIPC training forth daily, 3 days before entering the hypoxic room), combined group (rapid RIPC training plus acetazolamide) and controlled group. RIPC training, completed by Renqiao Remote Ischemic Conditioning Device (Doctormate®), will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. After the intervention, subjects will be exposed to 4500m altitude in a normobaric hypoxic chamber for 6 hours. The incidence of AMS and other data will be compared between groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Medicine Group | Active comparator | Drug: AcetazolamideStart orally take Acetazolamide 2 days before entering the hypoxic room. |
| RIPC Group | Active comparator | Device: Doctormate® (twice daily for 6 days)Start RIPC training twice daily, 6 days before entering the hypoxic room. |
| Rapid RIPC Group | Experimental | Device: Doctormate® (forth daily for 3 days)Start RIPC training forth daily, 3 days before entering the hypoxic room. |
| Combined Group | Experimental | Drug: Acetazolamide, Device: Doctormate® (forth daily for 3 days)Medicine + Rapid RIPC |
| Control Group | No intervention | –Subjects do not receive specific interventions before entering the hypoxic room. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- People who live in plain areas all year round and have not been to an altitude of 1500 meters or more in the past 30 days;
- Sign the informed consent form voluntarily.
Key exclusion criteria (9 listed)
- Chronic physical or mental diseases, including hypertension, diabetes, coronary heart disease, cerebrovascular disease, chronic obstructive pulmonary disease, migraine, anxiety, depression, insomnia, etc.;
- The female is pregnant or in the period of preparing for pregnancy or breast-feeding;
- Have a history of smoking;
- Have a history of thrombosis in the upper limbs;
- Severe damage to local soft tissues of upper limbs, fractures, etc.;
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 |
|---|---|---|
| AcetazolamideStart orally take acetazolamide 125mg twice daily, 2 days before entering the hypoxic chamber. Subjects will enter the hypoxic room at 9am on the third day. At that time, the subject should have taken the drug 5 times. | Drug | Combined Group, Medicine Group |
| Doctormate® (twice daily for 6 days)Start RIPC training twice daily, 6 days before entering the hypoxic chamber. RIPC will be induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®). Each training will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. Subjects will enter the hypoxic room at 9am on the seventh day. At that time, the subject should have finished 13 times of RIPC training. | Device | RIPC Group |
| Doctormate® (forth daily for 3 days)Start RIPC training forth daily, 3 days before entering the hypoxic chamber. RIPC will be induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®). Each training will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. Subjects will enter the hypoxic room at 9am on the forth day. At that time, the subject should have finished 13 times of RIPC training. | Device | Combined Group, Rapid RIPC Group |
Primary outcome
The incidence of acute mountain sickness.
Time frame: 6 hours after entering the hypoxic room.
The diagnosis of acute mountain sickness is based on '2018 Lake Louise Acute Mountain Sickness Score' , 'Acute Mountain Sickness-Cerebral Scores',etc. All subjects should finish the questionnaires to evaluate the total incidence.
The severity of acute mountain sickness.
Time frame: 6 hours after entering the hypoxic room.
The diagnosis of acute mountain sickness is based on '2018 Lake Louise Acute Mountain Sickness Score' , 'Acute Mountain Sickness-Cerebral Scores',etc. All subjects should finish the questionnaires to evaluate the total incidence.
Fingre pulse oximetry of the subjects.
Time frame: 6 hours after entering the hypoxic room.
Fingre pulse oximetry using pocket pulse oximeters will be noted.
3 secondary outcomes
Blood pressure of the subjects.
Time frame: 6 hours after entering the hypoxic room.
Heart rate of the subjects.
Time frame: 6 hours after entering the hypoxic room.
Respiratory rate of the subjects.
Time frame: 6 hours after entering the hypoxic room.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Derived from this study: PubMed 38166913Liu M, Jiao X, Li R, Li J, Wang L, Wang L, Wang Y, Lv C, Huang D, Wei R, Wang L, Ji X, Guo X. Effects of acetazolamide combined with remote ischemic preconditioning on risk of acute mountain sickness: a randomized clinical trial. BMC Med. 2024 Jan 2;22(1):4. doi: 10.1186/s12916-023-03209-7.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Xunming Ji, MD.PhD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetazolamide, Doctormate® (twice daily for 6 days) and Doctormate® (forth daily for 3 days) in people with Acute Mountain Sickness, run by Ji Xunming,MD,PhD at 1 site in China.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 3 Oct 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of acute mountain sickness. (time frame: 6 hours after entering the hypoxic room.). The study lists 3 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 NCT05023941, which also lists 1 linked publication.
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 3 Oct 2022.