- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05300477
Pharmacological Countermeasures for High Altitude
28 mars 2022 uppdaterad av: Roy Salgado, United States Army Research Institute of Environmental Medicine
Augmentation of Medical Readiness and Physical Performance at High Altitude Using Pharmacological Countermeasures
The aim of this randomized, double-blind study is to determine whether erythropoietin (Procrit) and acetazolamide: 1) mitigates altitude-induced decrements in performance at moderate altitude (3,000 m) and 2) mitigates altitude-induced decrements in performance and reduce acute mountain sickness during prolonged exposure to high altitude (4,300 m; 15 days).
Volunteers will complete 5 study phases: Phase 1) sea level baseline testing and a moderate altitude exposure; Phase 2) 4 week study intervention - randomly assigned to receive erythropoietin or placebo); Phase 3) 3 1/2 days of acetazolamide and a moderate altitude exposure; Phase 4) high altitude acclimatization - 15 days at Pikes Peak; and Phase 5) two week deacclimatization.
Test battery include VO2peak, 3.2 km treadmill time trial, measures of gas exchange and ventilation during rest and exercise, and blood collection.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study will use a double-blind randomized study design in which one group will receive erythropoietin and the other a placebo (saline) for 4 weeks, then both groups will receive acetazolamide.
Eighteen men and women volunteers will complete 5 study phases: Phase 1) two week sea level baseline testing (orientation, two VO2peak assessments, three 3.2 km treadmill time-trial, assessment of resting ventilation, venipuncture and capillary blood collection, and Hbmass assessment), and a VO2peak and 3.2 km treadmill time-trial moderate altitude (3,000 m); Phase 2) 4 week intervention to receive subcutaneously erythropoietin or placebo.
The erythropoietin (Procrit) dosing regimen will consist of 50 IU/kg three times a week (M-W-F); Phase 3) a second moderate altitude exposure (VO2peak and 3.2 km treadmill time-trial with acetazolamide administered (orally; 250 mg b.i.d) for 3 1/2 nights starting the day before the altitude exposure; Phase 4) high altitude acclimatization in which volunteers will reside for 15 days at 4,300 m altitude (Pikes Peak, Colorado Springs) completing multiple VO2peak assessments and 3.2 km treadmill time-trials, resting ventilation, venipuncture and capillary blood collection; and Phase 5) deacclimatization phase to assess changes in hematological biomarkers after returning from Pikes Peak.
This study consists of 41 visits over a ~10 week time period.
Visits will take place in Natick, MA and the Pikes Peak High Altitude Research Laboratory at Colorado Springs.
Additional assessments that will be completed multiple times during the study include: acute mountain sickness questionnaire, lung gas diffusion at rest and during exercise, oxygen saturation, arterialized blood gases (PO2, PCO2, pH, HCO3) and heart rate during rest, exercise, and sleep, and muscle tissue oxygenation.
The primary outcome is 3.2 km treadmill time-trial performance.
Secondary outcomes include: incidence and severity of acute mountain sickness, ventilation and gas exchange, Hbmass, Hb concentration, Hct, arterialized blood gases, lung diffusion at rest and during exercise, oxygen saturation and heart rate during rest, exercise, and sleep.
Studietyp
Interventionell
Inskrivning (Förväntat)
18
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Roy M Salgado, Ph.D.
- Telefonnummer: 508-206-2375
- E-post: roy.m.salgado.civ@mail.mil
Studieorter
-
-
Massachusetts
-
Natick, Massachusetts, Förenta staterna, 01760
- Rekrytering
- USARIEM
-
Kontakt:
- Roy M Salgado, Ph.D.
- Telefonnummer: 508-206-2375
- E-post: roy.m.salgado.civ@mail.mil
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 40 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Age 18-40 years
- In good health as determined by the Office of Medical Support & Oversight (OMSO) General Medical Clearance
- Runs at least 3 times per week and able to complete a two mile run in ≤ 21 minutes (Civilian Volunteers) or passed his/her most recent Army Combat Fitness Test (ACFT) (Military Volunteers Only)
- Willing to not exercise, or drink alcoholic and/or caffeinated beverages 24 hours prior to each testing session or the acute altitude exposure to 3,000 m
- Abstain from alcoholic beverages during the 15 day residence at the summit of Pikes Peak
- Abstain from drinking alcohol or caffeine at least 24 hours before a testing session during Phases 1 and 3
- Willing to stay and exercise in an altitude chamber (the size of a dorm room) for ~2.5 hours
- Wiling to reside at the summit of Pikes Peak (4,300 m altitude) and share dormitory area (bunk area, shower, and bathroom), potentially with people of the opposite sex for 15 days
- Up to date on COVID-19 vaccination
Exclusion Criteria:
- Women who are pregnant or planning to become pregnant during the study
- Taking prescription medication, or over-the-counter medications other than contraceptives, unless approved by OMSO & PI
- Born at altitudes greater than 2,100 m (7,000 ft)
- Living in areas that are more than 1,200 m (4,000 ft) or have traveled to areas that are more than 1,200 m for five days or more within the last 2 months
- Prior diagnosis of High Altitude Pulmonary Edema (HAPE) or High Altitude Cerebral Edema (HACE)
- Musculoskeletal injuries that compromise the ability to walk/run on a treadmill or hike steep terrain
- Abnormal blood count in accordance with OMSO - Normal Hb men: 12.6-17.7 g·dL-1 and women: 11.1-15.9 g·dL-1 or Normal Hct men: 37.5-48% and women: 34.0-45%, or presence of abnormal blood chemicals (hemoglobin S or Sickle Cell Trait)
- Any history of malignancy
- Personal or family history of blood clots
- Abnormal prothrombin time/partial thromboplastin time (PT/PTT) test or problems with blood clotting
- History of thromboembolic disease, hypertension, and known risk factors of cardiovascular disease
- Blood donation within 8 weeks of beginning the study
- History of seizures
- History of inflammatory bowel disease
- Any recent (within 4-6 weeks) and or expected history of prolonged periods of immobility or limited activity (including recent or upcoming surgery)
- No evidence of iron deficiency (ferritin < 45 ng/ml)
- Smokers or tobacco/nicotine (unless quit > 1 month prior to study orientation)
- History of asthma
- Experience recent (< 1 month of starting the study) cold, coughs, or respiratory tract infections
- Allergy to skin adhesive
- Known allergy to sulfa drugs
- Evidence of apnea or sleeping disorder
- Present condition of alcoholism, use of anabolic steroids, other substance abuse issues
- Inability to tolerate iron supplement
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Acetazolamide
Acetazolamide (orally) 250 mg twice a day for 3 1/2 days.
|
Carbonic Anhydrase Inhibitor
Andra namn:
|
Experimentell: Erythropoietin and Acetazolamide
Erythropoietin (subcutaneously) 50 IU /kg three times a week for 4 weeks.
After the 4 week Erythropoietin, acetazolamide (orally) 250 mg twice a day for 3 1/2 days.
|
Carbonic Anhydrase Inhibitor
Andra namn:
Hormone for red blood cell
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
3.2 km self-paced treadmill time trial performance
Tidsram: 35 minutes
|
Time to complete self-paced 3.2 km treadmill time trial (min:sec)
|
35 minutes
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
VO2peak
Tidsram: 30 minutes
|
Peak aerobic capacity will be assessed using a metabolic cart.
|
30 minutes
|
Lake Louise Acute Mountain Sickness Score
Tidsram: 10 minutes
|
Acute mountain sickness and severity will be assessed using the Lake Louise acute mountain sickness questionnaire.
This Likert scale assess acute mountain sickness with scores ranging from 0 to 12. Zero indicates no acute mountain sickness and 12 indicates severe acute mountain sickness.
|
10 minutes
|
Ventilation rate
Tidsram: 20 minutes
|
Ventilation rate will be assessed using a pneumotachometer.
|
20 minutes
|
Percent body fat
Tidsram: 10 minutes
|
Percent body fat will be assessed using Dual Energy X-ray Absorptiometry.
|
10 minutes
|
Oxygen Saturation
Tidsram: 35 minutes
|
Oxygen saturation will be assessed using a finger pulse oximeter.
|
35 minutes
|
Erythropoietin
Tidsram: 4 hours
|
Erythropoietin will be assessed using an ELISA.
|
4 hours
|
Hematocrit
Tidsram: 5 minutes
|
Hematocrit will be assessed using manual hematocrit method.
|
5 minutes
|
Reticulocyte
Tidsram: 2 hours
|
Reticulocyte will be assessed using a hematology analyzer.
|
2 hours
|
Ferritin
Tidsram: 2 hours
|
Ferritin will be assessed using an ELISA.
|
2 hours
|
C-reactive protein
Tidsram: 2 hours
|
C-reactive protein will be assessed using an ELISA.
|
2 hours
|
Soluble transferrin
Tidsram: 2 hours
|
Soluble transferrin will be assessed using an ELISA.
|
2 hours
|
Arterialized capillary PO2
Tidsram: 5 minutes
|
Arterialized capillary PO2 will be assessed using a blood gas analyzer.
|
5 minutes
|
Arterialized capillary PCO2
Tidsram: 5 minutes
|
Arterialized capillary PCO2 will be assessed using a blood gas analyzer.
|
5 minutes
|
Arterialized capillary pH
Tidsram: 5 minutes
|
Arterialized capillary pH will be assessed using a blood gas analyzer.
|
5 minutes
|
Hbmass
Tidsram: 20 minutes
|
Hbmass will be assessed using the CO-rebreathing procedure.
|
20 minutes
|
Muscle tissue oxygenation
Tidsram: 35 minutes
|
Muscle tissue oxygenation will be assessed using a non-invasive near-infrared spectroscopy.
|
35 minutes
|
Lung Diffusion of carbon monoxide
Tidsram: 35 minutes
|
Lung Diffusion of carbon monoxide will be assessed using a spirometer.
|
35 minutes
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
27 maj 2022
Primärt slutförande (Förväntat)
30 augusti 2022
Avslutad studie (Förväntat)
30 augusti 2022
Studieregistreringsdatum
Först inskickad
17 mars 2022
Först inskickad som uppfyllde QC-kriterierna
28 mars 2022
Första postat (Faktisk)
29 mars 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 mars 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 mars 2022
Senast verifierad
1 mars 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 21-06HC (M-10910)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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