The Impact of Cytochrome P450 Abnormalities in Patients With Delirium.

Completed

• Conditions: Delirium, Cytochrome P-450 Enzyme System
• Interventions: Diagnostic Test: Cytochrome P450 test

• Registration Number: NCT03829670
• Lead Sponsor: Wake Forest University Health Sciences

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.

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 Timeline

• Study Start: 2019-01-31
• Study First Submitted: 2019-02-01
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-04
• Primary Completion: 2020-06-24
• Study Completion: 2020-06-24
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients without delirium	Cytochrome P450 test	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.
Delirium Group	Cytochrome P450 test	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.

Primary Outcome Measures

Name	Time	Method
• Rates of cytochrome P450 in cases (delirium patients) compared to controls (non-delirium patients).	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.

Trial Locations

Locations (1)

Advocate Health Care; 🇺🇸 Park Ridge, Illinois, United States