- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05611385
Amphetamine Induced Adult Respiratory Distress Syndrome
High Incidence of Adult Respiratory Distress Syndrome Associated With Amphetamine Use in the Burn Population
Study Overview
Status
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
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Colton, California, United States, 92324
- Arrowhead Regional Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Positive for Amphetamine
Patients admitted to the burn unit that are positive for amphetamine
|
No Intervention
|
|
Negative for Amphetamine
Patients admitted to the burn unit that are negative for amphetamine
|
No Intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inhalation Injury
Time Frame: 24 hours
|
Documentation on admission of inhalation injury as defined by burned nasal hairs, burned facial skin, and carbonaceous sputum after admission to the hospital within the first 24 hours.
|
24 hours
|
|
Total Burn Surface Area
Time Frame: 24 hours
|
The total burn surface area of the patient on arrival to the hospital assessed within the first 24 hours.
With respect to the total burn surface area recorded only 2nd degree burns will be considered as defined as burns that affect the epidermis and dermis.
|
24 hours
|
|
Length of hospital stay
Time Frame: 180 days
|
The total length of hospitalization of individuals with burns and acute respiratory distress syndrome with a max of 180 days from admission.
|
180 days
|
|
Stroke Volume
Time Frame: Collected in the first 5 days after admission
|
Measurement of cardiovascular parameter (stroke volume) of patients with acute respiratory distress syndrome and total burn surface area between 20%-60% in the first 5 days of admission to the hospital.
|
Collected in the first 5 days after admission
|
|
Cardiac Output
Time Frame: Collected in the first 5 days after admission
|
Measurement of cardiovascular parameter (cardiac output) of patients with acute respiratory distress syndrome and total burn surface area between 20%-60% in the first 5 days of admission to the hospital.
|
Collected in the first 5 days after admission
|
|
Central Venous Pressure
Time Frame: Collected in the first 5 days after admission
|
Measurement of cardiovascular parameter (central venous pressure) of patients with acute respiratory distress syndrome and total burn surface area between 20%-60% in the first 5 days of admission to the hospital.
|
Collected in the first 5 days after admission
|
Collaborators and Investigators
Investigators
- Study Chair: Aldin Malkoc, MD, Arrowhead Regional Medical Center
- Principal Investigator: David T Wong, MD, Arrowhead Regional Medical Center
Publications and helpful links
General Publications
- Gonzales R, Mooney L, Rawson RA. The methamphetamine problem in the United States. Annu Rev Public Health. 2010;31:385-98. doi: 10.1146/annurev.publhealth.012809.103600.
- Busto U, Bendayan R, Sellers EM. Clinical pharmacokinetics of non-opiate abused drugs. Clin Pharmacokinet. 1989 Jan;16(1):1-26. doi: 10.2165/00003088-198916010-00001.
- Neeki MM, Kulczycki M, Toy J, Dong F, Lee C, Borger R, Adigopula S. Frequency of Methamphetamine Use as a Major Contributor Toward the Severity of Cardiomyopathy in Adults </=50 Years. Am J Cardiol. 2016 Aug 15;118(4):585-9. doi: 10.1016/j.amjcard.2016.05.057. Epub 2016 May 29.
- Kaye S, McKetin R, Duflou J, Darke S. Methamphetamine and cardiovascular pathology: a review of the evidence. Addiction. 2007 Aug;102(8):1204-11. doi: 10.1111/j.1360-0443.2007.01874.x. Epub 2007 Jun 12.
- Jafari Giv M. Exposure to Amphetamines Leads to Development of Amphetamine Type Stimulants Associated Cardiomyopathy (ATSAC). Cardiovasc Toxicol. 2017 Jan;17(1):13-24. doi: 10.1007/s12012-016-9385-8.
- Weir EK, Reeve HL, Huang JM, Michelakis E, Nelson DP, Hampl V, Archer SL. Anorexic agents aminorex, fenfluramine, and dexfenfluramine inhibit potassium current in rat pulmonary vascular smooth muscle and cause pulmonary vasoconstriction. Circulation. 1996 Nov 1;94(9):2216-20. doi: 10.1161/01.cir.94.9.2216.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Wounds and Injuries
- Disease
- Infant, Newborn, Diseases
- Infant, Premature, Diseases
- Thoracic Injuries
- Syndrome
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Lung Injury
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Amphetamine
Other Study ID Numbers
- 15-24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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