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Completed

NCT Number: NCT05023941

Optimization Strategy for the Prevention of AMS by RIPC 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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

Acetazolamide

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Blood pressure of the subjects.

    Time frame: 6 hours after entering the hypoxic room.

    Including systolic and diastolic pressure.

  2. Heart rate of the subjects.

    Time frame: 6 hours after entering the hypoxic room.

  3. Respiratory rate of the subjects.

    Time frame: 6 hours after entering the hypoxic room.

Sponsors and collaborators

Lead sponsor

Ji Xunming,MD,PhD

Other

Registry information

Official study title

Optimization Strategy for the Prevention of Acute Mountain Sickness by Remote Ischemic Preconditioning Combined With Acetazolamide

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 27, 2021
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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