NCT05023941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

August 15, 2021

Last Update Submit

September 30, 2022

Conditions

Acute Mountain Sickness

Keywords

Acute Mountain SicknessAcetazolamideRemote Ischemic Preconditioning

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    6 hours after entering the hypoxic room.

  • Fingre pulse oximetry of the subjects.

    Fingre pulse oximetry using pocket pulse oximeters will be noted.

    6 hours after entering the hypoxic room.

Secondary Outcomes (3)

  • Blood pressure of the subjects.

    6 hours after entering the hypoxic room.

  • Heart rate of the subjects.

    6 hours after entering the hypoxic room.

  • Respiratory rate of the subjects.

    6 hours after entering the hypoxic room.

Study Arms (5)

Medicine Group

ACTIVE COMPARATOR

Start orally take Acetazolamide 2 days before entering the hypoxic room.

Drug: Acetazolamide

RIPC Group

ACTIVE COMPARATOR

Start RIPC training twice daily, 6 days before entering the hypoxic room.

Device: Doctormate® (twice daily for 6 days)

Rapid RIPC Group

EXPERIMENTAL

Start RIPC training forth daily, 3 days before entering the hypoxic room.

Device: Doctormate® (forth daily for 3 days)

Combined Group

EXPERIMENTAL

Medicine + Rapid RIPC

Drug: AcetazolamideDevice: Doctormate® (forth daily for 3 days)

Control Group

NO INTERVENTION

Subjects do not receive specific interventions before entering the hypoxic room.

Interventions

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.

Combined GroupMedicine Group
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.

RIPC Group
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.

Combined GroupRapid RIPC Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (1)

  • 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.

    PMID: 38166913DERIVED

MeSH Terms

Conditions

Altitude Sickness

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Xunming Ji, MD.PhD

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the procedure, it was not possible to blind subjects to the intervention of medicine or RIPC.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
VP, Professor

Study Record Dates

First Submitted

August 15, 2021

First Posted

August 27, 2021

Study Start

December 1, 2021

Primary Completion

August 22, 2022

Study Completion

August 30, 2022

Last Updated

October 3, 2022

Record last verified: 2022-09

Locations

CN(1)