NCT02972411

Brief Summary

This study evaluates the safety and efficacy of the voluntary ventilatory response as prophylaxis for acute mountain sickness, measured by the Lake Louise Self-Report Score, comparing to a group using acetazolamide.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

7 months

First QC Date

October 25, 2016

Last Update Submit

November 21, 2016

Conditions

Altitude Sickness

Outcome Measures

Primary Outcomes (1)

  • Lake Louise Score

    Intensity and prevalence of Acute Mountain Sickness. During Ascent.

    Up to 5 months

Secondary Outcomes (5)

  • PETCO2

    Up to 5 months

  • Pulse oxygen saturation

    Up to 5 months

  • Respiratory rate

    Up to 5 months

  • Heart rate

    Up to 5 months

  • Borg Scale

    Up to 5 months

Other Outcomes (3)

  • Training satisfactory. PETCO2 below 20 mmHg

    Up to 6 months

  • Training satisfactory after Ascent. PETCO2 below 20mmHg

    Up to 6 months

  • hypoxic ventilatory response

    Up to 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Voluntary increase in respiration

Behavioral: Voluntary ventilatory response

Acetazolamide

ACTIVE COMPARATOR

Administration of Acetazolamide 125mg. since 24 hours before ascent and until 48 hours post altitude exposure, and absence of altitude sickness symptoms

Drug: Acetazolamide

Interventions

Voluntary ventilatory responseBEHAVIORAL

Training of the subjects for voluntary increase in the respiratory minute ventilation

Intervention
AcetazolamideDRUG

Acetazolamide 125mg. PO every 12 hours since 24 hours before ascent, until 48 hours at high altitude

Acetazolamide

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Living at lower altitude than 900 meters

You may not qualify if:

  • Cardiac or pulmonary comorbidity
  • Smoking
  • Infectious disease during the last 30 days
  • BMI\> 30
  • Pharmaceutical use as diuretics, corticosteroids, acetazolamide, or anti -inflammatory drugs during the 2 weeks prior to the study
  • A history of high altitude cerebral edema or high altitude pulmonary edema
  • Cardiovascular risk factors such as a personal history of cardiovascular disease, familial history of major adverse cardiovascular events (MACE) at age younger than 45 yrs, hypercholesterolemia and stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

110 Sports and health center

Santiago, 8320000, Chile

RECRUITING

Related Publications (10)

  • Bartsch P, Swenson ER. Clinical practice: Acute high-altitude illnesses. N Engl J Med. 2013 Jun 13;368(24):2294-302. doi: 10.1056/NEJMcp1214870.

    PMID: 23758234BACKGROUND

  • Buijze GA, Hopman MT. Controlled hyperventilation after training may accelerate altitude acclimatization. Wilderness Environ Med. 2014 Dec;25(4):484-6. doi: 10.1016/j.wem.2014.04.009. Epub 2014 Oct 14. No abstract available.

    PMID: 25443751BACKGROUND

  • Luks AM, McIntosh SE, Grissom CK, Auerbach PS, Rodway GW, Schoene RB, Zafren K, Hackett PH; Wilderness Medical Society. Wilderness Medical Society consensus guidelines for the prevention and treatment of acute altitude illness. Wilderness Environ Med. 2010 Jun;21(2):146-55. doi: 10.1016/j.wem.2010.03.002. Epub 2010 Mar 10.

    PMID: 20591379BACKGROUND

  • Richalet JP, Larmignat P, Poitrine E, Letournel M, Canoui-Poitrine F. Physiological risk factors for severe high-altitude illness: a prospective cohort study. Am J Respir Crit Care Med. 2012 Jan 15;185(2):192-8. doi: 10.1164/rccm.201108-1396OC. Epub 2011 Oct 27.

    PMID: 22071330BACKGROUND

  • Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010 Jun 1;152(11):726-32. doi: 10.7326/0003-4819-152-11-201006010-00232. Epub 2010 Mar 24.

    PMID: 20335313BACKGROUND

  • Vargas M, Osorio J, Jimenez D, Moraga F, Sepulveda M, Del Solar J, Hudson C, Cortes G, Leon A. [Acute mountain sickness at 3500 and 4250 m. A study of symptom, incidence and severity]. Rev Med Chil. 2001 Feb;129(2):166-72. Spanish.

    PMID: 11351468BACKGROUND

  • Acetazolamide in control of acute mountain sickness. Lancet. 1981 Jan 24;1(8213):180-3.

    PMID: 6109857BACKGROUND

  • Bernardi L, Passino C, Spadacini G, Bonfichi M, Arcaini L, Malcovati L, Bandinelli G, Schneider A, Keyl C, Feil P, Greene RE, Bernasconi C. Reduced hypoxic ventilatory response with preserved blood oxygenation in yoga trainees and Himalayan Buddhist monks at altitude: evidence of a different adaptive strategy? Eur J Appl Physiol. 2007 Mar;99(5):511-8. doi: 10.1007/s00421-006-0373-8. Epub 2007 Jan 6.

    PMID: 17206440BACKGROUND

  • Bernardi L, Schneider A, Pomidori L, Paolucci E, Cogo A. Hypoxic ventilatory response in successful extreme altitude climbers. Eur Respir J. 2006 Jan;27(1):165-71. doi: 10.1183/09031936.06.00015805.

    PMID: 16387950BACKGROUND

  • Moore LG, Harrison GL, McCullough RE, McCullough RG, Micco AJ, Tucker A, Weil JV, Reeves JT. Low acute hypoxic ventilatory response and hypoxic depression in acute altitude sickness. J Appl Physiol (1985). 1986 Apr;60(4):1407-12. doi: 10.1152/jappl.1986.60.4.1407.

    PMID: 3084449BACKGROUND

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

  • Sebastián Drago, MD

    Hospital del Trabajador Santiago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastián Drago, MD

CONTACT

+56992191310sebadrago@gmail.com

Juan Campodónico, MD

CONTACT

+56981379351campodonicouc@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

October 25, 2016

First Posted

November 23, 2016

Study Start

October 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

November 23, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)