Interfaith Medical Center
New York, 11414, United States
NCT Number: NCT04818827
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
Looking for future studies?
Notify Me18 year–90 year
All sexes
Observational
New York, 11414, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 10 months (throughout the study period)
The two groups were compared for all-cause mortality during the ICU stay
Time frame: 10 months (throughout the study period)
The two groups were compared for hospital length of stay
Time frame: 10 months (throughout the study period)
The patients in two groups were compared for the duration of ventilator days
Time frame: 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
Time frame: 10 months (throughout the study period)
Routine blood samples were obtained that included serum creatinine. Acute kidney injury is defined as per KDIGO
Time frame: 10 months (throughout the study period)
The patients were classified as hemodynamic instability if received vasopressors or ionotropes
Time frame: 10 months (throughout the study period)
All patients in the study were routinely screened for delirium using the CAM-ICU score
Interfaith Medical Center
Other
Ketamine Infusion as Sedative Analgesic in Severe ARDS on Mechanically Ventilated Patients
Acronym: KISS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05299346
COVID-19, COVID-19 Pandemic
Mölndal, Västra Götaland County, Sweden
View Trial DetailsNCT03642249
Confusion, Delirium
Taipei, Taiwan
View Trial DetailsNCT02603731
Confusion, Delirium
Køge, Denmark
View Trial DetailsNCT03050021
Confusion, Delirium
Seoul, South Korea
View Trial Details