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The Impact of Cytochrome P450 Abnormalities in Patients With Delirium.

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ClinicalTrials.gov Identifier: NCT03829670
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Advocate Health Care

Brief 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. 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.

Condition or disease Intervention/treatment
Delirium, Cytochrome P-450 Enzyme System Diagnostic Test: Cytochrome P450 test

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
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Impact of Cytochrome P450 Abnormalities in Patients With Delirium. A Pilot Study.
Actual Study Start Date : January 31, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort Intervention/treatment
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.
Diagnostic Test: Cytochrome P450 test
Blood samples will be drawn for cytochrome P450 testing.
Other Name: CYP2D6, CYP2C9, CYP2C19

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.
Diagnostic Test: Cytochrome P450 test
Blood samples will be drawn for cytochrome P450 testing.
Other Name: CYP2D6, CYP2C9, CYP2C19




Primary Outcome Measures :
  1. • 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.


Biospecimen Retention:   Samples With DNA
One pink (K2EDTA) 6.0 mL (also acceptable: light blue (3.2% sodium citrate) 2.7 mL)


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  1. Patients age 18 and older admitted to the ALGH (Advocate Lutheran General Hospital) rehabilitation unit
  2. One or more of the Following Principle Diagnosis:

    Principle stroke diagnosis Principle Cardiac-Post cardiac surgery Principle Spinal surgery

  3. 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:

  1. Stroke patients with any diagnosed aphasia
  2. Spinal surgery, as a result of trauma
  3. Pregnant women
  4. Prisoners
  5. 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.)
  6. Patients with cirrhosis and liver failure
  7. Patients with renal failure requiring dialysis
  8. Recent blood transfusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829670


Contacts
Contact: David Ronin 847-723-2500 david.ronin@advocatehealth.com
Contact: Monika Kapinos 847-723-7951 monika.kapinos@advocatehealth.com

Locations
United States, Illinois
David Ronin Recruiting
Park Ridge, Illinois, United States, 60068
Contact: David Ronin, MD    847-318-2500    david.ronin@advocatehealth.com   
Contact: Monika Kapinos    847-723-7951    monika.kapinos@advocatehealth.com   
Principal Investigator: David I Ronin, MD         
Sub-Investigator: Mary Schmidt, PhD         
Sponsors and Collaborators
Advocate Health Care

Additional Information:
Responsible Party: Advocate Health Care
ClinicalTrials.gov Identifier: NCT03829670     History of Changes
Other Study ID Numbers: AHC IRB 6915
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will de-identify the data once the study is completed.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders