Delirium, Cytochrome P-450 Enzyme SystemNCT03829670
The Impact of Cytochrome P450 Abnormalities in Patients With Delirium.
An observational study of Delirium, Cytochrome P-450 Enzyme System, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Objectives: 1. To examine whether patients with delirium have higher prevalence of cytochrome-P450 abnormalities compared to patients without delirium. 2. To examine whether the severity of delirium is related to a specific cytochrome P450 genotype. 3. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Delirium, Cytochrome P-450 Enzyme System
- What is being tested?
- Cytochrome P450 test
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2019to 24 Jun 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Delirium, Cytochrome P-450 Enzyme System
- Being tested
- Cytochrome P450 test
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytochrome P450 testDiagnostic test
Also called CYP2D6, CYP2C9, CYP2C19
Blood samples will be drawn for cytochrome P450 testing.
| Study group | Role | What they receive |
|---|---|---|
| Delirium Group | 1. UBACC: University of California, San Diego Brief Assessment of Capacity to Consent.
2. The participant may decline participation after this UBACC (University of California, San Diego Brief Assessment of Capacity to Consent) assessment and will be removed from the study.
3. The Short IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly) is administered to the legally authorized representative or caregiver by Dr. Schmidt. If the potential participant scores 3.3 or lower, the participant will continue in the delirium group. If higher, patient likely with pre-existing dementia. These patients are not eligible for study participation.
4. Delirium Rating Scale 98 will be performed on the ALGH (Advocate Lutheran General Hospital) rehabilitation unit
5. Cytochrome P450 testing
6. Delirium Status: Admission, Hospital Discharge, Outpatient Visit
7. FIM (The Functional Independence Measure) scores on admission and discharge. FIM efficiency score. Receives: Diagnostic Test: Cytochrome P450 test | |
| Patients without delirium | 1. Cytochrome P450 testing
2. Delirium Status: Admission, Hospital Discharge, Outpatient Visit
3. FIM (The Functional Independence Measure) scores on admission and discharge. FIM efficiency score. Receives: Diagnostic Test: Cytochrome P450 test |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Rates of cytochrome P450 in cases (delirium patients) compared to controls (non-delirium patients).
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start31 Jan 2019
- Primary completion24 Jun 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium, Cytochrome P-450 Enzyme SystemStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Ronin, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829670
- Sponsor's protocol ID
- AHC IRB 6915
- Status last verified
- Sep 2024
- First submitted
- 1 Feb 2019
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will de-identify the data once the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cytochrome P450 Abnormalities in Patients With Delirium. A Pilot Study.
- ClinicalTrials.gov ID
- NCT03829670
- Acronym / sponsor ID
- AHC IRB 6915
- Conditions
- Delirium, Cytochrome P-450 Enzyme System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 4 Feb 2019 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirium Group | – | Diagnostic Test: Cytochrome P450 test1. UBACC: University of California, San Diego Brief Assessment of Capacity to Consent. 2. The participant may decline participation after this UBACC (University of California, San Diego Brief Assessment of Capacity to Consent) assessment and will be removed from the study. 3. The Short IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly) is administered to the legally authorized representative or caregiver by Dr. Schmidt. If the potential participant scores 3.3 or lower, the participant will continue in the delirium group. If higher, patient likely with pre-existing dementia. These patients are not eligible for study participation. 4. Delirium Rating Scale 98 will be performed on the ALGH (Advocate Lutheran General Hospital) rehabilitation unit 5. Cytochrome P450 testing 6. Delirium Status: Admission, Hospital Discharge, Outpatient Visit 7. FIM (The Functional Independence Measure) scores on admission and discharge. FIM efficiency score. |
| Patients without delirium | – | Diagnostic Test: Cytochrome P450 test1. Cytochrome P450 testing 2. Delirium Status: Admission, Hospital Discharge, Outpatient Visit 3. FIM (The Functional Independence Measure) scores on admission and discharge. FIM efficiency score. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.)
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 |
|---|---|---|
| Cytochrome P450 testAlso: CYP2D6, CYP2C9, CYP2C19Blood samples will be drawn for cytochrome P450 testing. | Diagnostic test | Delirium Group, Patients without delirium |
Primary outcome
• 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.
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 4 Oct 2024.
- Pinto, N., \& Dolan, M. E. (2011). Clinically relevant genetic variations in drug metabolizing enzymes. Current Drug Metabolism, 12(5), 487-97.Link provided by the sponsor.
- Maldonado, J. R. (2008). Delirium in the Acute Care Setting: Characteristics, Diagnosis and Treatment. Critical Care Clinics.Link provided by the sponsor.
- Individual participant dataSharing planned: No. We will de-identify the data once the study is completed.
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.
David Ronin, MD principal investigator
Wake Forest University Health Sciences
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 Delirium, Cytochrome P-450 Enzyme System, run by Wake Forest University Health Sciences 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 4 inclusion and 8 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 4 Oct 2024. 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?
• Rates of cytochrome P450 in cases (delirium patients) compared to controls (non-delirium patients). (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2024.