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Effects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude

Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: High Altitude

Intervention: Ibuprofen (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: University of California, San Francisco

Summary

Ibuprofen is often taken by travelers to high altitude to treat the symptoms of acute mountain sickness such as headache and malaise. However, the blunting of inflammation by ibuprofen may slow the process of acclimatization to altitude, which relies on mediators of inflammation for adjustments in breathing. The study randomizes healthy subjects to receive ibuprofen or placebo and then ascend to altitude (12,500 feet). Blood cytokines and non-invasive measurements of blood and tissue oxygen levels will be made for 48 hours at altitude. The hypothesis being tested is that subjects receiving ibuprofen will have lower blood and tissue oxygen levels after 48 hours at altitude than will placebo subjects.

Clinical Details

Official title: Effects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome:

blood cytokine levels

cerebral blood flow

Secondary outcome: pulse oximetry

Detailed description: The study will begin with 2 days of studies in San Francisco (sea level baseline). Measurements will include non-invasive measurements of blood and tissue oxygen and venous blood draws for cytokine levels. The altitude part of the study involves ascent to the University of California's White Mountain Research Center Barcroft Laboratory, at 12,500 feet elevation. The subjects will remain at that altitude for at least 48 hours for measurements of oxygenation and blood cytokines.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- healthy subjects

Exclusion Criteria:

- pregnancy

- contraindication to taking ibuprofen

Locations and Contacts

White Mountain Research Center, Bishop, California 95740, United States; Not yet recruiting
Philip Bickler, MD, PhD, Phone: 415-476-1411, Email: bicklerp@anesthesia.ucsf.edu
John Feiner, Phone: 4154768624, Email: feinerj@anesthesia.ucsf.edu
Philip Bickler, MD, PhD, Principal Investigator

UCSF Hypoxia Research Laboratory, San Francisco, California 94143, United States; Not yet recruiting
Paul Au, BS, Phone: 415-476-1412, Email: aupaul@anesthesia.ucsf.edu
Philip Bickler, MD, PHD, Phone: 4154761411
Philip Bickler, MD, PhD, Principal Investigator

Additional Information

Starting date: September 2014
Last updated: September 9, 2014

Page last updated: August 23, 2015

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