Delirium, Intensive Care Unit Syndrome, Mechanical Ventilation Complication, Sedatives and Hypnotics Causing Adverse Effects in Therapeutic Use
Conditions
Keywords
ketamine, Mechanical ventilation, sedative analgesic, hospital length of stay, Number of ventilator days, mortality
Brief summary
To evaluate whether ketamine is a safe sedative-analgesic agent to be used in an intensive care unit (ICU) setting as compared to traditionally used agents such as propofol, opioids, and midazolam
Detailed description
According to the 2018 Clinical Practice Guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the intensive care unit (ICU), nonbenzodiazepine sedatives (such as propofol and dexmedetomidine) are preferable to benzodiazepine sedatives (such as midazolam and lorazepam) in critically ill, mechanically ventilated patients. Moreover, continuous use of benzodiazepine (more than 48 hours) has been associated with a risk of prolonged sedation and delirium. On the other hand, though propofol has a remarkable safety profile, it carries unfavorable side effects such as dose-dependent hypotension, hypertriglyceridemia, pancreatitis, and propofol syndrome (which is a rare but potentially fatal complication, associated with high-dose propofol infusions, and characterized by severe metabolic acidosis and circulatory collapse). During the coronavirus disease 2019 (COVID-19) pandemic, an enormous number of patients required mechanical ventilation, which led to the shortage of traditional sedatives such as propofol, dexmedetomidine, midazolam, and lorazepam in the hospitals. In this challenging time, ketamine was used as an alternative sedative infusion. This study is to evaluate whether ketamine is safer compared to other sedatives in severe COVID related ARDS patients.
Interventions
None listed
Sponsors
Interfaith Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 with an arterial partial pressure of oxygen divided by the inspired oxygen concentration (P/F) ratio \< 150 with a minimum 5 cm of positive end-expiratory pressure on a mechanical ventilator
Exclusion criteria
* post-cardiac arrest status, * premorbid diagnosis of dementia, * dependency on extra-corporeal therapies prior to or during ICU stay
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause mortality | 10 months (throughout the study period) | The two groups were compared for all-cause mortality during the ICU stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of ventilator days | 10 months (throughout the study period) | The patients in two groups were compared for the duration of ventilator days |
| Infectious complications | 10 months (throughout the study period) | The patients in both groups were cultured as clinically suspected for infection. This included blood culture, urine culture and BAL/TTA |
| Hospital length of stay | 10 months (throughout the study period) | The two groups were compared for hospital length of stay |
| Hemodynamic instability | 10 months (throughout the study period) | The patients were classified as hemodynamic instability if received vasopressors or ionotropes |
| Delirium after extubation | 10 months (throughout the study period) | All patients in the study were routinely screened for delirium using the CAM-ICU score |
| Acute Kidney Injury | 10 months (throughout the study period) | Routine blood samples were obtained that included serum creatinine. Acute kidney injury is defined as per KDIGO |
Countries
United States
Outcome results
None listed