Ketamine Infusion as Sedative Analgesic in Severe ARDS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ketamine Infusion as Sedative Analgesic in Severe ARDS on Mechanically Ventilated Patients

Conditions
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Intensive Care Unit Syndrome, Mechanical Ventilation Complication, Sedatives and Hypnotics Causing Adverse Effects in Therapeutic Use, Delirium

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ketamine group<br>This cohort includes patients who received ketamine as a sedative analgesic agent during mechanical ventilation | |
| Non Ketamine group<br>This cohort includes patients who received sedatives other than ketamine during mechanical ventilation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-Cause mortality | The two groups were compared for all-cause mortality during the ICU stay | 10 months (throughout the study period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | The two groups were compared for hospital length of stay | 10 months (throughout the study period) | 
| Duration of ventilator days | The patients in two groups were compared for the duration of ventilator days | 10 months (throughout the study period) | 
| Infectious complications | The patients in both groups were cultured as clinically suspected for infection. This included blood culture, urine culture and BAL/TTA | 10 months (throughout the study period) | 
| Acute Kidney Injury | Routine blood samples were obtained that included serum creatinine. Acute kidney injury is defined as per KDIGO | 10 months (throughout the study period) | 
| Hemodynamic instability | The patients were classified as hemodynamic instability if received vasopressors or ionotropes | 10 months (throughout the study period) | 
| Delirium after extubation | All patients in the study were routinely screened for delirium using the CAM-ICU score | 10 months (throughout the study period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketamine, Mechanical ventilation, sedative analgesic, hospital length of stay, Number of ventilator days, mortality