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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of this project is to test how fentanyl, an analgesic currently employed in the pre-hospital setting by the US Army, alters the capacity to tolerate a hemorrhagic insult in humans.
Pain management on the battlefield is critical for the wellbeing of the soldier. Given that a hemorrhagic injury on the battlefield is virtually always associated with pain, it is paramount that the selected pain medication does not disrupt appropriate physiological mechanisms that are beneficial towards the maintenance of blood pressure and vital organ blood flow during that hemorrhagic insult. Current guidelines for the selection of pain medications of a hemorrhaging soldier are based upon limited scientific evidence, with the vast majority of supporting studies being conducted on anesthetized animals. Thus, the interaction between hemorrhagic shock and pain medications commonly employed on the battlefield is yet to be determined in the conscious humans.
With this background, we will test the hypothesis that fentanyl will impair the capacity for a conscious human to tolerate a hemorrhagic insult.
The obtained data will provide the necessary scientific evidence in humans to support the Committee on Tactical Combat Casualty Care (CoTCCC) guidelines on the analgesic of choice for moderate to severe injuries where the casualty is in hemorrhagic shock. Notably, such data will identify the analgesic that least compromises a human's ability to tolerate a hemorrhagic insult, ultimately providing critical information to the combat medic on which analgesic should be employed for such an injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl | Experimental | Fentanyl will be administered intravenously during one visit. |
|
| Placebo | Placebo Comparator | Placebo (saline) will be administered intravenously during one visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | Subjects will receive 75 ug Fentanyl while the effects of this drug on tolerance to a hemorrhagic insult will be assessed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Stress Index | Tolerance to a simulated hemorrhagic challenge will be assessed, for both the placebo and fentanyl limbs, by causing progressive central hypovolemia via lower-body negative pressure (LBNP). This progressive lower-body negative pressure challenge will be performed until the onset of syncopal symptoms (defined as: profound bradycardia, a precipitous drop in arterial blood pressure and accompanying narrowing of pulse pressure, a sustained systolic blood pressure less than 80 mmHg, and/or subjective symptoms such as light-headedness, sweating, nausea, or dizziness). The primary variable will be the quantification of lower-body negative pressure that is required to cause these symptoms. This quantification will be objectively measured via a cumulative stress index which is calculated as the sum of the product of the LBNP level and the duration of each level, until test termination (i.e., 40 mmHg x 3 min + 50 mmHg x 3 min, etc). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure Pain Tolerance | Pain assessments will be conducted using a digital algometer to obtain maximum pain thresholds caused by pressure. This pain assessment technique is conducted by applying the tip of a hand-held digital algometer on the subject's digit. Force is gradually increased and the peak force is recorded when the subject first reports a painful sensation. Removal of the pressure from the algometer immediately relieves the painful sensation and the subject can voluntarily stop the test at any time. This assessment will be performed after the subject has received placebo and fentanyl. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig G Crandall, PhD | Institute for Exercise and Environmental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
The individual participant data (IPD) from this study are available from the principal investigator upon reasonable request.
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Forty-one adults enrolled by providing written and oral consent. Of these 38, three adults were deemed not to be eligible based upon screening criteria prior to randomization. Therefore, only 38 adults were 'enrolled and randomized' (see 'Participant Flow' below).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo, Then Fentanyl | Participants first received Placebo (75 ug) each (<5mins). After a washout period of lying down for resting for sometime , then Fentanyl (75 ug) is administered to each participant (<5 mins) |
| FG001 | Fentanyl, Then Placebo | Participants first received Fentanyl (75 ug) visit. each (<5mins). After a washout period of lying down for resting for sometime , then Placebo (75 ug) is administered to each participant (<5 mins) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrolled & Randomized |
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| First Visit |
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| Washout (at Least 48 Hours) |
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| Second Visit |
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Forty-one adults enrolled by providing written and oral consent. Of these 38, three adults were deemed not to be eligible based upon screening criteria prior to randomization. Therefore, only 38 adults were 'enrolled and randomized' (see 'Participant Flow' module).
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Stress Index | Tolerance to a simulated hemorrhagic challenge will be assessed, for both the placebo and fentanyl limbs, by causing progressive central hypovolemia via lower-body negative pressure (LBNP). This progressive lower-body negative pressure challenge will be performed until the onset of syncopal symptoms (defined as: profound bradycardia, a precipitous drop in arterial blood pressure and accompanying narrowing of pulse pressure, a sustained systolic blood pressure less than 80 mmHg, and/or subjective symptoms such as light-headedness, sweating, nausea, or dizziness). The primary variable will be the quantification of lower-body negative pressure that is required to cause these symptoms. This quantification will be objectively measured via a cumulative stress index which is calculated as the sum of the product of the LBNP level and the duration of each level, until test termination (i.e., 40 mmHg x 3 min + 50 mmHg x 3 min, etc). | Posted | Mean | Standard Deviation | mmHg x minutes | 12 months |
|
Adverse event data were collected from until discharge from the final data collection visit, which typically occurred 6 to 12 months after consent/screening.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Experimental visit with Placebo administration | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Craig Crandall | University of Texas Southwestern Medical Center | 2143454623 | craigcrandall@texashealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 4, 2019 | Oct 22, 2021 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 26, 2020 | Oct 21, 2021 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 4, 2019 | Oct 22, 2021 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Other | Subjects will receive saline while the effects of this drug on tolerance to a hemorrhagic insult will be assessed. |
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| 12 months |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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Fentanyl will be administered intravenously during one visit. Fentanyl: Subjects will receive 75 ug Fentanyl while the effects of this drug on tolerance to a hemorrhagic insult will be assessed. |
| OG001 | Placebo | Placebo (saline) will be administered intravenously during one visit. Placebo: Subjects will receive saline while the effects of this drug on tolerance to a hemorrhagic insult will be assessed. |
|
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| Secondary | Pressure Pain Tolerance | Pain assessments will be conducted using a digital algometer to obtain maximum pain thresholds caused by pressure. This pain assessment technique is conducted by applying the tip of a hand-held digital algometer on the subject's digit. Force is gradually increased and the peak force is recorded when the subject first reports a painful sensation. Removal of the pressure from the algometer immediately relieves the painful sensation and the subject can voluntarily stop the test at any time. This assessment will be performed after the subject has received placebo and fentanyl. | Pressure pain tolerance was evaluated in a subset of individuals | Posted | Median | Inter-Quartile Range | Kilograms | 12 months |
|
|
|
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Fentanyl | Experimental visit with Fentanyl administration | 0 | 28 | 0 | 28 | 0 | 28 |
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