Ketamine Infusion as Sedative Analgesic in Severe ARDS

Completed

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

• Registration Number: NCT04818827
• Lead Sponsor: Interfaith Medical Center

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.

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2020-11-30
• Study Completion: 2021-02-14
• Status Verified: 2021-03
• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-23
• Last Update Submitted: 2021-03-23
• Study First Posted: 2021-03-26
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-Cause mortality	10 months (throughout the study period)	The two groups were compared for all-cause mortality during the ICU stay

Secondary Outcome Measures

Name	Time	Method
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
Hemodynamic instability	10 months (throughout the study period)	The patients were classified as hemodynamic instability if received vasopressors or ionotropes
Hospital length of stay	10 months (throughout the study period)	The two groups were compared for hospital length of stay
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
Delirium after extubation	10 months (throughout the study period)	All patients in the study were routinely screened for delirium using the CAM-ICU score
Duration of ventilator days	10 months (throughout the study period)	The patients in two groups were compared for the duration of ventilator days

Trial Locations

Locations (1)

Interfaith Medical Center; 🇺🇸 New York, New York, United States