<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03829670</url>
  </required_header>
  <id_info>
    <org_study_id>AHC IRB 6915</org_study_id>
    <nct_id>NCT03829670</nct_id>
  </id_info>
  <brief_title>The Impact of Cytochrome P450 Abnormalities in Patients With Delirium.</brief_title>
  <official_title>The Impact of Cytochrome P450 Abnormalities in Patients With Delirium. A Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Advocate Health Care</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Advocate Health Care</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives:&#xD;
&#xD;
        1. To examine whether patients with delirium have higher prevalence of cytochrome-P450&#xD;
           abnormalities compared to patients without delirium.&#xD;
&#xD;
        2. To examine whether the severity of delirium is related to a specific cytochrome P450&#xD;
           genotype.&#xD;
&#xD;
        3. To examine the persistence of delirium at 6-8 weeks stratified by presence of cytochrome&#xD;
           p450 abnormalities&#xD;
&#xD;
        4. To examine whether delirium persistence is impacted by types of medications administered&#xD;
           during their hospital stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Delirium is a costly and devastating illness affecting older patients in the hospital. Its&#xD;
      prevalence increases as patients get older and sicker. There is scientific evidence that&#xD;
      delirium affects cognitive function for a prolonged period of time and in many cases&#xD;
      irreversibly. The economic burden on health care and emotional burden on the caregivers of&#xD;
      patients with delirium is tremendous. We think that our study may contribute to developing&#xD;
      prevention strategies for delirium in the hospital. We propose genetic testing of older&#xD;
      patients to determine their ability to metabolize commonly used medications in the hospital.&#xD;
      This will give medical professionals and pharmacists an ability to adjust dosages of&#xD;
      medications based on the patient's genetic profile.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">June 24, 2020</completion_date>
  <primary_completion_date type="Actual">June 24, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>• Rates of cytochrome P450 in cases (delirium patients) compared to controls (non-delirium patients).</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">13</enrollment>
  <condition>Delirium, Cytochrome P-450 Enzyme System</condition>
  <arm_group>
    <arm_group_label>Delirium Group</arm_group_label>
    <description>UBACC: University of California, San Diego Brief Assessment of Capacity to Consent.&#xD;
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.&#xD;
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.&#xD;
Delirium Rating Scale 98 will be performed on the ALGH (Advocate Lutheran General Hospital) rehabilitation unit&#xD;
Cytochrome P450 testing&#xD;
Delirium Status: Admission, Hospital Discharge, Outpatient Visit&#xD;
FIM (The Functional Independence Measure) scores on admission and discharge. FIM efficiency score.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients without delirium</arm_group_label>
    <description>Cytochrome P450 testing&#xD;
Delirium Status: Admission, Hospital Discharge, Outpatient Visit&#xD;
FIM (The Functional Independence Measure) scores on admission and discharge. FIM efficiency score.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cytochrome P450 test</intervention_name>
    <description>Blood samples will be drawn for cytochrome P450 testing.</description>
    <arm_group_label>Delirium Group</arm_group_label>
    <arm_group_label>Patients without delirium</arm_group_label>
    <other_name>CYP2D6, CYP2C9, CYP2C19</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      One pink (K2EDTA) 6.0 mL (also acceptable: light blue (3.2% sodium citrate) 2.7 mL)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to the Rehabilitation Unit at Lutheran General Hospital will be&#xD;
        approached to participate in this case-control study. Patients will be assigned to the case&#xD;
        group once identified with delirium by the Psychology staff. Control group will consist of&#xD;
        patients without delirium upon assessment by the Psychology staff. The Delirious patients&#xD;
        will then be matched to a control patient hospitalized in the Rehabilitation Lutheran&#xD;
        General Unit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients age 18 and older admitted to the ALGH (Advocate Lutheran General Hospital)&#xD;
             rehabilitation unit&#xD;
&#xD;
          2. One or more of the Following Principle Diagnosis:&#xD;
&#xD;
             Principle stroke diagnosis Principle Cardiac-Post cardiac surgery Principle Spinal&#xD;
             surgery&#xD;
&#xD;
          3. Non-English speakers are not anticipated. However, there is an available interpreter&#xD;
             services already on the unit and this interpreter's services will be utilized.&#xD;
             https://www.languageline.com/ However, we will utilize that AHC IRB approved short&#xD;
             forms if a potential subject presents itself.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Stroke patients with any diagnosed aphasia&#xD;
&#xD;
          2. Spinal surgery, as a result of trauma&#xD;
&#xD;
          3. Pregnant women&#xD;
&#xD;
          4. Prisoners&#xD;
&#xD;
          5. Patients with dementia (score of greater than 3.3 on short IQCODE questionnaire) (Long&#xD;
             Term Cognitive Impairment after Critical Illness, NEJM, 2013, Pandharipande et al.)&#xD;
&#xD;
          6. Patients with cirrhosis and liver failure&#xD;
&#xD;
          7. Patients with renal failure requiring dialysis&#xD;
&#xD;
          8. Recent blood transfusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>David Ronin</name>
      <address>
        <city>Park Ridge</city>
        <state>Illinois</state>
        <zip>60068</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://doi.org/10.2174/138920011795495321</url>
    <description>Pinto, N., &amp; Dolan, M. E. (2011). Clinically relevant genetic variations in drug metabolizing enzymes. Current Drug Metabolism, 12(5), 487-97.</description>
  </link>
  <link>
    <url>https://doi.org/10.1016/j.ccc.2008.05.008</url>
    <description>Maldonado, J. R. (2008). Delirium in the Acute Care Setting: Characteristics, Diagnosis and Treatment. Critical Care Clinics.</description>
  </link>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will de-identify the data once the study is completed.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03829670
org study id: AHC IRB 6915
nct id: NCT03829670
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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. To examine the persistence of delirium at 6-8 weeks stratified by presence of cytochrome
           p450 abnormalities

        4. To examine whether delirium persistence is impacted by types of medications administered
           during their hospital stay.
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.
observational model: Case-Control
time perspective: Prospective
measure: • Rates of cytochrome P450 in cases (delirium patients) compared to controls (non-delirium patients).
time frame: 2 years
description: 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.
arm group label: Delirium Group
description: UBACC: University of California, San Diego Brief Assessment of Capacity to Consent.
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.
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.
Delirium Rating Scale 98 will be performed on the ALGH (Advocate Lutheran General Hospital) rehabilitation unit
Cytochrome P450 testing
Delirium Status: Admission, Hospital Discharge, Outpatient Visit
FIM (The Functional Independence Measure) scores on admission and discharge. FIM efficiency score.
arm group label: Patients without delirium
description: Cytochrome P450 testing
Delirium Status: Admission, Hospital Discharge, Outpatient Visit
FIM (The Functional Independence Measure) scores on admission and discharge. FIM efficiency score.
intervention type: Diagnostic Test
intervention name: Cytochrome P450 test
description: Blood samples will be drawn for cytochrome P450 testing.
arm group label: Delirium Group
arm group label: Patients without delirium
other name: CYP2D6, CYP2C9, CYP2C19
One pink (K2EDTA) 6.0 mL (also acceptable: light blue (3.2% sodium citrate) 2.7 mL)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: United States
url: https://doi.org/10.2174/138920011795495321
description: Pinto, N., & Dolan, M. E. (2011). Clinically relevant genetic variations in drug metabolizing enzymes. Current Drug Metabolism, 12(5), 487-97.
url: https://doi.org/10.1016/j.ccc.2008.05.008
description: Maldonado, J. R. (2008). Delirium in the Acute Care Setting: Characteristics, Diagnosis and Treatment. Critical Care Clinics.
responsible party type: Sponsor
mesh term: Delirium
sharing ipd: No
ipd description: We will de-identify the data once the study is completed.