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

Phase 4

Completed

• Conditions: Acute Mountain Sickness
• Interventions: Device: Doctormate® (twice daily for 6 days); Device: Doctormate® (forth daily for 3 days); Drug: Acetazolamide

• Registration Number: NCT05023941
• Lead Sponsor: Ji Xunming,MD,PhD

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 Timeline

• Study First Submitted: 2021-08-15
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-27
• Study Start: 2021-12-01
• Primary Completion: 2022-08-22
• Study Completion: 2022-08-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-30
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
RIPC Group	Doctormate® (twice daily for 6 days)	Start RIPC training twice daily, 6 days before entering the hypoxic room.
Rapid RIPC Group	Doctormate® (forth daily for 3 days)	Start RIPC training forth daily, 3 days before entering the hypoxic room.
Combined Group	Doctormate® (forth daily for 3 days)	Medicine + Rapid RIPC
Medicine Group	Acetazolamide	Start orally take Acetazolamide 2 days before entering the hypoxic room.
Combined Group	Acetazolamide	Medicine + Rapid RIPC

Primary Outcome Measures

Name	Time	Method
The incidence of acute mountain sickness.	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.	6 hours after entering the hypoxic room.	Fingre pulse oximetry using pocket pulse oximeters will be noted.
The severity of acute mountain sickness.	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.

Secondary Outcome Measures

Name	Time	Method
Blood pressure of the subjects.	6 hours after entering the hypoxic room.	Including systolic and diastolic pressure.
Respiratory rate of the subjects.	6 hours after entering the hypoxic room.
Heart rate of the subjects.	6 hours after entering the hypoxic room.

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China