The Impact of Cytochrome P450 Abnormalities in Patients With Delirium.

NCT ID: NCT03829670

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2020-06-24

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.

Conditions

Delirium, Cytochrome P-450 Enzyme System

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Cytochrome P450 test

Intervention Type: DIAGNOSTIC_TEST

Blood samples will be drawn for cytochrome P450 testing.

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.

Cytochrome P450 test

Intervention Type: DIAGNOSTIC_TEST

Blood samples will be drawn for cytochrome P450 testing.

Interventions

Cytochrome P450 test

Blood samples will be drawn for cytochrome P450 testing.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

CYP2D6, CYP2C9, CYP2C19

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Ronin, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Advocate Health Care

Park Ridge, Illinois, United States

Countries

United States

Related Links

https://doi.org/10.2174/138920011795495321

Pinto, N., \& Dolan, M. E. (2011). Clinically relevant genetic variations in drug metabolizing enzymes. Current Drug Metabolism, 12(5), 487-97.

https://doi.org/10.1016/j.ccc.2008.05.008

Maldonado, J. R. (2008). Delirium in the Acute Care Setting: Characteristics, Diagnosis and Treatment. Critical Care Clinics.

Other Identifiers

AHC IRB 6915

Identifier Type: -

Identifier Source: org_study_id