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

NCT05023941 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2022-10-03

No results posted yet for this study

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.

Conditions

  • Acute Mountain Sickness

Interventions

DRUG

Acetazolamide

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.

DEVICE

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

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.

Sponsors & Collaborators

  • Ji Xunming,MD,PhD

    lead OTHER

Principal Investigators

  • Xunming Ji, MD.PhD · Xuanwu Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-08-22
Completion
2022-08-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05023941 on ClinicalTrials.gov