- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03829670
The Impact of Cytochrome P450 Abnormalities in Patients With Delirium.
July 14, 2020 updated by: Advocate Health Care
The Impact of Cytochrome P450 Abnormalities in Patients With Delirium. A Pilot Study.
Objectives:
- To examine whether patients with delirium have higher prevalence of cytochrome-P450 abnormalities compared to patients without delirium.
- To examine whether the severity of delirium is related to a specific cytochrome P450 genotype.
- To examine the persistence of delirium at 6-8 weeks stratified by presence of cytochrome p450 abnormalities
- To examine whether delirium persistence is impacted by types of medications administered during their hospital stay.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Delirium is a costly and devastating illness affecting older patients in the hospital.
Its prevalence increases as patients get older and sicker.
There is scientific evidence that delirium affects cognitive function for a prolonged period of time and in many cases irreversibly.
The economic burden on health care and emotional burden on the caregivers of patients with delirium is tremendous.
We think that our study may contribute to developing prevention strategies for delirium in the hospital.
We propose genetic testing of older patients to determine their ability to metabolize commonly used medications in the hospital.
This will give medical professionals and pharmacists an ability to adjust dosages of medications based on the patient's genetic profile.
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Park Ridge, Illinois, United States, 60068
- David Ronin
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to the Rehabilitation Unit at Lutheran General Hospital will be approached to participate in this case-control study.
Patients will be assigned to the case group once identified with delirium by the Psychology staff.
Control group will consist of patients without delirium upon assessment by the Psychology staff.
The Delirious patients will then be matched to a control patient hospitalized in the Rehabilitation Lutheran General Unit.
Description
Inclusion Criteria:
- Patients age 18 and older admitted to the ALGH (Advocate Lutheran General Hospital) rehabilitation unit
One or more of the Following Principle Diagnosis:
Principle stroke diagnosis Principle Cardiac-Post cardiac surgery Principle Spinal surgery
- Non-English speakers are not anticipated. However, there is an available interpreter services already on the unit and this interpreter's services will be utilized. https://www.languageline.com/ However, we will utilize that AHC IRB approved short forms if a potential subject presents itself.
Exclusion Criteria:
- Stroke patients with any diagnosed aphasia
- Spinal surgery, as a result of trauma
- Pregnant women
- Prisoners
- Patients with dementia (score of greater than 3.3 on short IQCODE questionnaire) (Long Term Cognitive Impairment after Critical Illness, NEJM, 2013, Pandharipande et al.)
- Patients with cirrhosis and liver failure
- Patients with renal failure requiring dialysis
- Recent blood transfusion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Delirium Group
|
Blood samples will be drawn for cytochrome P450 testing.
Other Names:
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Patients without delirium
|
Blood samples will be drawn for cytochrome P450 testing.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
• Rates of cytochrome P450 in cases (delirium patients) compared to controls (non-delirium patients).
Time Frame: 2 years
|
Statistical Analysis Plan: Descriptive statistics will be presented as mean ± SD for continuous variables and percentage/count for dichotomous/categorical variables.
Chi-square test and t-test will be used to compare distribution of variables of interest between the two groups.
Logistic regression analysis will be performed to estimate the risk of PEP while adjusting for all potential confounding factors.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2019
Primary Completion (Actual)
June 24, 2020
Study Completion (Actual)
June 24, 2020
Study Registration Dates
First Submitted
February 1, 2019
First Submitted That Met QC Criteria
February 1, 2019
First Posted (Actual)
February 4, 2019
Study Record Updates
Last Update Posted (Actual)
July 16, 2020
Last Update Submitted That Met QC Criteria
July 14, 2020
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHC IRB 6915
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We will de-identify the data once the study is completed.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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