Amphetamine Induced Adult Respiratory Distress Syndrome

NCT05611385 | Completed

• 1 other identifier: 15-24
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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

Conditions

Burns; Acute Lung Injury; Acute Respiratory Distress Syndrome; Methamphetamine Abuse

Outcome Measures

Primary Outcomes (6)

• 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.

  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

Study Arms (2)

Positive for Amphetamine

Patients admitted to the burn unit that are positive for amphetamine

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

Other: Difference in development of Acute Lung Injury in Amphetamine positive and negative patients

Interventions

Difference in development of Acute Lung Injury in Amphetamine positive and negative patients OTHER

No Intervention

Negative for Amphetamine; Positive for Amphetamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Under 18 years of age

Sponsors & Collaborators

• Arrowhead Regional Medical Center: lead

Study Sites (1)

Arrowhead Regional Medical Center

Colton, California, 92324, United States

Location

Related Publications (6)

• 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.

  PMID: 2565176 BACKGROUND

• 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.

  PMID: 20070191 BACKGROUND

• 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.

  PMID: 27374605 BACKGROUND

• 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.

  PMID: 17565561 BACKGROUND

• 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.

  PMID: 27663745 BACKGROUND

• 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.

  PMID: 8901674 BACKGROUND

MeSH Terms

Conditions

Burns; Acute Lung Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Wounds and Injuries; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Aldin Malkoc, MD

  Arrowhead Regional Medical Center

  STUDY CHAIR

• David T Wong, MD

  Arrowhead Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 10, 2022
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)