NCT05611385|Completed
Amphetamine Induced Adult Respiratory Distress Syndrome
High Incidence of Adult Respiratory Distress Syndrome Associated With Amphetamine Use in the Burn Population
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High Incidence of Adult Respiratory Distress Syndrome Associated With Amphetamine Use in the Burn Population
Sponsor study identifier
observational
49
1 country
1
Study Start
January 1, 2019
Actual (reported)Primary Completion
January 1, 2020
Actual (reported)Study Completion
January 1, 2020
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2019
Actual (reported)January 1, 2020
Actual (reported)January 1, 2020
Actual (reported)October 26, 2022
Actual (reported)November 10, 2022
Actual (reported)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.
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.
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.
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.
Patients admitted to the burn unit that are positive for amphetamine
Patients admitted to the burn unit that are negative for amphetamine
No Intervention
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Arrowhead Regional Medical Center
Colton, California, 92324, United States
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.
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.
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.
Aldin Malkoc, MD
Arrowhead Regional Medical Center
David T Wong, MD
Arrowhead Regional Medical Center
49 participants (actual enrollment reported by the registry).
First Submitted
October 26, 2022
First Posted
November 10, 2022
Study Start
January 1, 2019
Actual (reported)N-Acetyl-cysteine in Early Acute Respiratory Distress Syndrome
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.
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.
Collected in the first 5 days after admission
Contact the study team to confirm eligibility.
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.
Primary Completion
January 1, 2020
Actual (reported)Study Completion
January 1, 2020
Actual (reported)Last Updated
November 10, 2022
Record last verified: 2022-11
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Source: ClinicalTrials.gov.
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