BurnsNCT05611385
Amphetamine Induced Adult Respiratory Distress Syndrome
An observational study of Burns and Acute Lung Injury, run by Arrowhead Regional Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Acute Lung Injury, Acute Respiratory Distress Syndrome
- What is being tested?
- Difference in development of Acute Lung Injury in Amphetamine positive and negative patients
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Total body surface area burns between 20% and 60% admitted to the burn unit
Who cannot join
- Under 18 years of age
- Burns outside of the inclusion ratio
Trial locations and contacts
1 site in 1 country.
United States1 site
Arrowhead Regional Medical Center
Colton, California, 92324
About this study
Official title: High Incidence of Adult Respiratory Distress Syndrome Associated With Amphetamine Use in the Burn Population
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
Read the 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
- Being tested
- Difference in development of Acute Lung Injury in Amphetamine positive and negative patients
- Medical subject headings
- Burns, Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difference in development of Acute Lung Injury in Amphetamine positive and negative patientsOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Positive for Amphetamine | Patients admitted to the burn unit that are positive for amphetamine Receives: Other: Difference in development of Acute Lung Injury in Amphetamine positive and negative patients | |
| Negative for Amphetamine | Patients admitted to the burn unit that are negative for amphetamine Receives: Other: Difference in development of Acute Lung Injury in Amphetamine positive and negative patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhalation Injury
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.
Measured: 24 hours
Total Burn Surface Area
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.
Measured: 24 hours
Length of hospital stay
The total length of hospitalization of individuals with burns and acute respiratory distress syndrome with a max of 180 days from admission.
Measured: 180 days
Stroke Volume
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.
Measured: Collected in the first 5 days after admission
Cardiac Output
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.
Measured: Collected in the first 5 days after admission
Central Venous Pressure
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.
Measured: Collected in the first 5 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrowhead Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aldin Malkoc, MD, Study chair, Arrowhead Regional Medical CenterDavid T Wong, MD, Principal investigator, Arrowhead Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611385
- Sponsor's protocol ID
- 15-24
- Status last verified
- Nov 2022
- First submitted
- 26 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2565176Gonzales 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.
PubMed 20070191Neeki 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.
PubMed 27374605Kaye 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.
PubMed 17565561Jafari 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.
PubMed 27663745Weir 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.
PubMed 8901674
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Incidence of Adult Respiratory Distress Syndrome Associated With Amphetamine Use in the Burn Population
- ClinicalTrials.gov ID
- NCT05611385
- Acronym / sponsor ID
- 15-24
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Arrowhead Regional Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive for Amphetamine | – | Other: Difference in development of Acute Lung Injury in Amphetamine positive and negative patientsPatients admitted to the burn unit that are positive for amphetamine |
| Negative for Amphetamine | – | Other: Difference in development of Acute Lung Injury in Amphetamine positive and negative patientsPatients admitted to the burn unit that are negative for amphetamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Total body surface area burns between 20% and 60% admitted to the burn unit
Key exclusion criteria (2 listed)
- Under 18 years of age
- Burns outside of the inclusion ratio
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Difference in development of Acute Lung Injury in Amphetamine positive and negative patientsNo Intervention | Other | Negative for Amphetamine, Positive for Amphetamine |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Background: PubMed 2565176Busto 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.
- Background: PubMed 20070191Gonzales 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.
- Background: PubMed 27374605Neeki 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.
- Background: PubMed 17565561Kaye 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.
- Background: PubMed 27663745Jafari 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.
- Background: PubMed 8901674Weir 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aldin Malkoc, MD study chair
Arrowhead Regional Medical Center
David T Wong, MD principal investigator
Arrowhead Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns and Acute Lung Injury, run by Arrowhead Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhalation Injury (time frame: 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05611385, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.