NCT02299921 · University of Colorado, Denver
Effect of Alcohol and Drugs of Abuse on Immune Function in Critically Ill Patients With Respiratory Failure
What this study is about
This study plans to learn more about people who are sick in the hospital with a lung infection, or respiratory failure. Respiratory failure, or severe lung failure, is a life-threatening disease. When it happens, the lungs have trouble carrying out their normal function of getting oxygen into the blood, and removing carbon dioxide from the body.
View original scientific description
This study plans to learn more about people who are sick in the hospital with a lung infection, or respiratory failure. Respiratory failure, or severe lung failure, is a life-threatening disease. When it happens, the lungs have trouble carrying out their normal function of getting oxygen into the blood, and removing carbon dioxide from the body. Investigators are conducting this study to see what drinking too much alcohol, using tobacco products, or using drugs (both legal and illegal) may do to lung infections and respiratory failure. Subjects are asked to be in this research study because they are thought to have a lung infection and may also have respiratory failure. Alcohol, tobacco, and drug use have been linked to lung infections, respiratory failure, and even death, but the reasons for this aren't known. People who use unhealthy amounts of alcohol, tobacco, and or drugs may be more at risk for lung infections, and for severe complications due to lung infection. Subject participation is important whether or not you use alcohol and or drugs.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Specific Aim 1: Adult medical ICU patients admitted to the University of Colorado Hospital for a primary respiratory problem, and who are expected to require ICU care ≥48 hrs
- Specific Aim 2: (1) Adult medical ICU patients with respiratory failure (due to underlying lung pathology) and who require endotracheal intubation and mechanical ventilation. (2) Adult medical and other ICU patients with respiratory failure, not related to a lung condition, and who require endotracheal intubation and mechanical ventilation. (3) Adult ICU patients previously admitted to the University of Colorado Hospital for a primary respiratory problem, and who required care ≥48 hrs.
Exclusion criteria
- , Specific Aim 1 and 2:
- Patients who are expected to require ICU care \<48 hrs
- Patients admitted to the ICU who are not ICU status (being housed for space issues)
- Patient is unlikely to survive 48 hours
- Patient is on comfort care (hospice measures)
- Patients less than 18 or greater than 90 years of age
- Patient is a prisoner
- ICU attending declines enrollment of patient
- Patients who are pregnant
- Patients who have significant anemia, defined as Hgb\<8% or Hct\<24%, or who have evidence of active bleeding. For bronchoscopy portion of Specific Aim 2.
- Patients who are on either a fraction of inspired oxygen inspired oxygen fraction (FiO2)\>80% or positive end expiratory pressure (PEEP) \>10 cm H20
- Patients with platelets less than 30,000(chronically)
- Patients who are expected to undergo a spontaneous breathing trial within the next 4 hours
- Patients with an order or plan to extubate in the next 4 hours
- Patients who have an endotracheal tube (ETT) \<7.5 F
- Patients who are currently dangerously agitated
- Pregnant women Exclusion criteria (outpatients ONLY for SA2 (3)):
- Patients who required ICU care \<48 hrs
- Patients less than 18 or greater than 90 years of age
- Patient is a prisoner
- Patients who are pregnant
- Residency \> 40 miles from UCH clinics
- non-English or non-Spanish speaking
- Inability to perform study procedures (i.e. physical disability)
- unable to perform pulmonary function testing
- diagnosis of chronic pulmonary disease (e.g. COPD)
- diagnosis of chronic neurodegenerative disease or severe dementia
- history of anoxic or traumatic brain injury
- prior ICU hospitalization at a non-UCH facility.
Where
- Aurora, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 8, 2024 · Source of record for eligibility and locations