Pharmacological Countermeasures for High Altitude
2022年3月28日 更新者: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.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
18
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Roy M Salgado, Ph.D.
- 电话号码:508-206-2375
- 邮箱:roy.m.salgado.civ@mail.mil
学习地点
-
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Massachusetts
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Natick、Massachusetts、美国、01760
- 招聘中
- USARIEM
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接触:
- Roy M Salgado, Ph.D.
- 电话号码:508-206-2375
- 邮箱:roy.m.salgado.civ@mail.mil
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 40年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Acetazolamide
Acetazolamide (orally) 250 mg twice a day for 3 1/2 days.
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Carbonic Anhydrase Inhibitor
其他名称:
|
实验性的: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
其他名称:
Hormone for red blood cell
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
3.2 km self-paced treadmill time trial performance
大体时间:35 minutes
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Time to complete self-paced 3.2 km treadmill time trial (min:sec)
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35 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
VO2peak
大体时间:30 minutes
|
Peak aerobic capacity will be assessed using a metabolic cart.
|
30 minutes
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Lake Louise Acute Mountain Sickness Score
大体时间: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
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Ventilation rate
大体时间:20 minutes
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Ventilation rate will be assessed using a pneumotachometer.
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20 minutes
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Percent body fat
大体时间:10 minutes
|
Percent body fat will be assessed using Dual Energy X-ray Absorptiometry.
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10 minutes
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Oxygen Saturation
大体时间:35 minutes
|
Oxygen saturation will be assessed using a finger pulse oximeter.
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35 minutes
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Erythropoietin
大体时间:4 hours
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Erythropoietin will be assessed using an ELISA.
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4 hours
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Hematocrit
大体时间:5 minutes
|
Hematocrit will be assessed using manual hematocrit method.
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5 minutes
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Reticulocyte
大体时间:2 hours
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Reticulocyte will be assessed using a hematology analyzer.
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2 hours
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Ferritin
大体时间:2 hours
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Ferritin will be assessed using an ELISA.
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2 hours
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C-reactive protein
大体时间:2 hours
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C-reactive protein will be assessed using an ELISA.
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2 hours
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Soluble transferrin
大体时间:2 hours
|
Soluble transferrin will be assessed using an ELISA.
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2 hours
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Arterialized capillary PO2
大体时间:5 minutes
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Arterialized capillary PO2 will be assessed using a blood gas analyzer.
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5 minutes
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Arterialized capillary PCO2
大体时间:5 minutes
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Arterialized capillary PCO2 will be assessed using a blood gas analyzer.
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5 minutes
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Arterialized capillary pH
大体时间:5 minutes
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Arterialized capillary pH will be assessed using a blood gas analyzer.
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5 minutes
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Hbmass
大体时间:20 minutes
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Hbmass will be assessed using the CO-rebreathing procedure.
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20 minutes
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Muscle tissue oxygenation
大体时间:35 minutes
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Muscle tissue oxygenation will be assessed using a non-invasive near-infrared spectroscopy.
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35 minutes
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Lung Diffusion of carbon monoxide
大体时间:35 minutes
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Lung Diffusion of carbon monoxide will be assessed using a spirometer.
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35 minutes
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2022年5月27日
初级完成 (预期的)
2022年8月30日
研究完成 (预期的)
2022年8月30日
研究注册日期
首次提交
2022年3月17日
首先提交符合 QC 标准的
2022年3月28日
首次发布 (实际的)
2022年3月29日
研究记录更新
最后更新发布 (实际的)
2022年3月29日
上次提交的符合 QC 标准的更新
2022年3月28日
最后验证
2022年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.