The Impact of Cytochrome P450 Abnormalities in Patients With Delirium.

Delirium, Cytochrome P-450 Enzyme System Clinical Trial

Official title:

The Impact of Cytochrome P450 Abnormalities in Patients With Delirium. A Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03829670
• Other study ID #: AHC IRB 6915
• Status: Completed
• Start date: January 31, 2019
• Est. completion date: June 24, 2020

Study information

• Verified date: February 2019
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 24, 2020
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Delirium, Cytochrome P-450 Enzyme System

Intervention

Diagnostic Test:
• Cytochrome P450 test
Blood samples will be drawn for cytochrome P450 testing.

Locations

Country	Name	City	State
United States	David Ronin	Park Ridge	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Advocate Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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.	2 years

External Links

•   Maldonado, J. R. (2008). Delirium in the Acute Care Setting: Characteristics, Diagnosis and Treatment. Critical Care Clinics.
•   Pinto, N., & Dolan, M. E. (2011). Clinically relevant genetic variations in drug metabolizing enzymes. Current Drug Metabolism, 12(5), 487-97.