Optimization Strategy for the Prevention of AMS by RIPC Combined With Acetazolamide

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Brief Title

Optimization Strategy for the Prevention of AMS by RIPC Combined With Acetazolamide

Official Title

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

Brief 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.
    

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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

The incidence of acute mountain sickness.

Secondary Outcome

 Blood pressure of the subjects.

Condition

Acute Mountain Sickness

Intervention

Acetazolamide

Study Arms / Comparison Groups

 Medicine Group
Description:  Start orally take Acetazolamide 2 days before entering the hypoxic room.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

250

Start Date

September 1, 2021

Completion Date

December 31, 2022

Primary Completion Date

June 30, 2022

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Xunming Ji, MD.PhD, +86-010-83198952, [email protected]



Administrative Informations


NCT ID

NCT05023941

Organization ID

RIPC-Acet-AMS


Responsible Party

Sponsor-Investigator

Study Sponsor

Ji Xunming,MD,PhD


Study Sponsor

Xunming Ji, MD.PhD, Principal Investigator, Xuanwu Hospital, Beijing


Verification Date

August 2021