Clinical trial NCT05611385: Amphetamine Induced Adult Respiratory Distress Syndrome
Official title: High Incidence of Adult Respiratory Distress Syndrome Associated With Amphetamine Use in the Burn Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Acute Lung Injury
Acute Respiratory Distress Syndrome
Methamphetamine Abuse
Lead sponsor: Arrowhead Regional Medical Center
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was completed at Arrowhead Regional Medical Center County Burn Center in Colton, California, which operates as the only burn center for San Bernardino, Inyo, Mono and Riverside Counties. ARMC covers one of the largest geographical areas in the United States. Due to the high prevalence of methamphetamine use, this location sees a high incidence of burn patients who either use amphetamine or are the result of methamphetamine lab explosions.

Brief summary: Methamphetamine and amphetamine has various cardiovascular and central nervous system effects. Long-term use is associated with many adverse health effects including cardiomyopathy, hemorrhagic, and ischemic stroke. Death is usually caused by cardiovascular collapse and while amphetamine abuse has been considered as a potential cause of acute respiratory distress syndrome, the reports are usually anecdotal. This investigation considers reviewing individuals with few to zero medical conditions who develop acute respiratory distress syndrome and are methamphetamine positive

Detailed description: Methamphetamine and amphetamine has various cardiovascular and central nervous system effects. Initially prescribed in the 1930s for respiratory ailments such as asthma, current clinical indications of amphetamine range from treatment of attention deficit hyperactivity disorder to narcolepsy. The mechanism of action is primarily potentiation of release of monoamine neurotransmitters, mainly dopamine and norepinephrine, from presynaptic nerve endings into the synaptic space, in addition to attenuation of monoamine metabolism by inhibiting monoamine oxidase. This in turn leads to an increase in sympathetic tone by alpha and beta adrenergic receptor activation, resulting in elevations in heart rate, respiratory rate, and vascular tone. Long-term use is associated with many adverse health effects including cardiomyopathy, hemorrhagic and ischemic stroke. Other long-term associations include increased violent behavior, documented increased motor vehicle accidents, and clandestine manufacturing of the drug.

Methamphetamine has also been associated with deleterious effects on society as a whole; it is credited as a cause of increase in rates of crime, abuse, and unemployment, and associated with great economic burden. A significant portion of healthcare resources consumed are rooted in the emergency department, particularly in trauma. Studies previously performed have demonstrated that methamphetamine use among patients that present to trauma centers has been continually increasing. Death is usually caused by cardiovascular collapse and while amphetamine abuse has been considered as a potential cause of acute respiratory distress syndrome, the reports are usually anecdotal. This investigation considers reviewing individuals with few to zero medical conditions who develop acute respiratory distress syndrome and are methamphetamine positive

Eligibility criteria: Inclusion Criteria:

* Total body surface area burns between 20% and 60% admitted to the burn unit

Exclusion Criteria:

* Under 18 years of age
* Burns outside of the inclusion ratio

Primary outcomes:
measure: Inhalation Injury
timeFrame: 24 hours
measure: Total Burn Surface Area
timeFrame: 24 hours
measure: Length of hospital stay
timeFrame: 180 days
measure: Stroke Volume
timeFrame: Collected in the first 5 days after admission
measure: Cardiac Output
timeFrame: Collected in the first 5 days after admission
measure: Central Venous Pressure
timeFrame: Collected in the first 5 days after admission
Secondary outcomes:
Other outcomes:
Locations:
city: Colton
country: United States
facility: Arrowhead Regional Medical Center
state: California
Study officials:
affiliation: Arrowhead Regional Medical Center
name: Aldin Malkoc, MD
role: STUDY_CHAIR
affiliation: Arrowhead Regional Medical Center
name: David T Wong, MD
role: PRINCIPAL_INVESTIGATOR
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