Delirium
Conditions
Keywords
cephalosporins, Antibiotics
Brief summary
The goal of this observational study is to learn if the use of ceftazidime, cefepime, and ceftriaxone impacts the incidence of delirium in elderly patients (aged 65 and older) with infections. The main questions it aims to answer are: Does the administration of these antibiotics increase the incidence of delirium in elderly patients? How do renal and hepatic dose adjustments affect the likelihood of delirium? Researchers will observe elderly patients receiving either ceftazidime, cefepime, or ceftriaxone for infection management to see if these antibiotics contribute to the onset of delirium, and then assessing the severity of the delirium. Participants will: Be assessed for delirium using the CAM (Confusion Assessment Method) at 2, 4, and 6 days after starting treatment. Have their QSOFA (Quick Sequential Organ Failure Assessment) and NEWS (National Early Warning Score) tracked to evaluate their overall health status. Undergo dose adjustments based on renal and hepatic function as part of their treatment. Use the DRS.R89 score to assess delirium if it occurred.
Detailed description
This observational study aims to assess the incidence, severity, and recovery of delirium in older adult patients treated with ceftazidime, cefepime, or ceftriaxone for infections. Delirium onset and severity will be monitored using the Confusion Assessment Method (CAM) and the Delirium Rating Scale (DRS-R98), alongside the Sequential Organ Failure Assessment (SOFA) scores, and National Early Warning Score (NEWS) for assessing the severity of infection. Key variables include the presence of delirium at Days 2, 4, and 6, and evaluating the severity of delirium and recovery time, as well as the impact of renal and hepatic dose adjustments. By examining these factors, the study seeks to provide insights into safer antibiotic use and dosing strategies in elderly patients, with the goal of reducing delirium risk and improving patient outcomes.
Interventions
None listed
Sponsors
Alexandria University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Older adult patients aged 65 years or above. * Hospitalized patients in Alexandria university hospitals diagnosed with infection and treated with selected cephalosporins (Ceftriaxone, Ceftazidime, or Cefepime). * Patients without a history of Pre-existing delirium prior to hospitalization.
Exclusion criteria
* Patients with contraindications or allergies to cephalosporins. * Patients with septic shock. * Current use of medications known to cause delirium (anticholinergics, benzodiazepines, or opioid analgesics). * Current or recent substance abuse (patients with a history of alcohol or drug abuse within the past year, or currently undergoing withdrawal). 5. Recent surgical procedures (patients who have undergone major surgery, particularly those requiring general anesthesia, within the last 30 days). * Electrolyte imbalance (patients with severe electrolyte disturbances such as hypernatremia, hyponatremia, hypercalcemia or hypocalcemia at the time of study entry). * Patients with End-stage renal disease requiring dialysis. * Patients with severe liver disease (e.g., Child-C). * Pain management issues: Patients with severe, uncontrolled pain that might independently affect cognitive function.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Delirium Diagnosed by Confusion Assessment Method (CAM) | Within 6 days after initiation of antibiotic treatment | : Determine the incidence of delirium in older-adult patients treated with selected cephalosporins, diagnosed using the Confusion Assessment Method (CAM). Units of Measure: Number of participants with CAM-positive delirium Details: The CAM is a validated diagnostic tool for delirium based on four features: (1) acute onset and fluctuating course, (2) inattention, (3) disorganized thinking, and (4) altered level of consciousness. Delirium is diagnosed when both features 1 and 2 are present, and either feature 3 or 4. Incidence will be calculated as the number of patients who meet the CAM criteria divided by the total number of patients in each treatment arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delirium severity | On the day of delirium diagnosis | Description: Severity of delirium measured using the Delirium Rating Scale-Revised-98 (DRS-R-98). Units of Measure: DRS-R-98 score (0-39 for severity scale) Delirium Rating Scale-Revised-98 (DRS-R-98) is a standardized tool used to assess the severity and presence of delirium. It includes 16 items - 13 severity items and 3 diagnostic items - and is rated based on clinical observation and patient interaction. Scoring Overview: 13 severity items are scored from 0 to 3 (maximum score = 39) 3 diagnostic items are scored from 0 to 3 (maximum score = 9) Total maximum score = 46 |
| Length of hospital stay | From hospital admission until discharge, assessed up to 90 days. | Total number of days the patient remained hospitalized during the study period. |
| Mortality rate | From hospital admission until in-hospital death or discharge, assessed up to 90 days | Proportion of patients who died during hospitalization period. |
| Time to delirium onset | From the date of antibiotic initiation until the first documented CAM-positive delirium event, assessed up to 6 days | Number of days from the initiation of the antibiotic to the onset of clinically confirmed delirium (via Confusion Assessment Method \[CAM\]). |
Countries
Egypt
Contacts
Primary ContactRana Kh Draz, Pharm D.
Backup ContactNoha A Hamdy, Ph.D
Outcome results
None listed