Clinical trial NCT04818827: Ketamine Infusion as Sedative Analgesic in Severe ARDS
Official title: Ketamine Infusion as Sedative Analgesic in Severe ARDS on Mechanically Ventilated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit Syndrome
Mechanical Ventilation Complication
Sedatives and Hypnotics Causing Adverse Effects in Therapeutic Use
Delirium
Keywords: ketamine
Mechanical ventilation
sedative analgesic
hospital length of stay
Number of ventilator days
mortality
Lead sponsor: Interfaith Medical Center
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes patients who are on mechanical ventilators and classified as moderate to severe ARDS with a PF ratio \< 150.

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-Cause mortality
timeFrame: 10 months (throughout the study period)
Secondary outcomes:
measure: Hospital length of stay
timeFrame: 10 months (throughout the study period)
measure: Duration of ventilator days
timeFrame: 10 months (throughout the study period)
measure: Infectious complications
timeFrame: 10 months (throughout the study period)
measure: Acute Kidney Injury
timeFrame: 10 months (throughout the study period)
measure: Hemodynamic instability
timeFrame: 10 months (throughout the study period)
measure: Delirium after extubation
timeFrame: 10 months (throughout the study period)
Other outcomes:
Locations:
city: New York
country: United States
facility: Interfaith Medical Center
state: New York
Study officials:
affiliation: Interfaith Medical Center
name: RAMAKANTH PATA, MD
role: PRINCIPAL_INVESTIGATOR
References: