Ketamine Infusion as Sedative Analgesic in Severe ARDS

Delirium Clinical Trial

— KISS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04818827
• Other study ID #: KISS 1.0
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: February 14, 2021

Study information

• Verified date: March 2021
• Source: Interfaith Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: February 14, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Interfaith Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Interfaith Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-Cause mortality	The two groups were compared for all-cause mortality during the ICU stay	10 months (throughout the study period)
Secondary	Hospital length of stay	The two groups were compared for hospital length of stay	10 months (throughout the study period)
Secondary	Duration of ventilator days	The patients in two groups were compared for the duration of ventilator days	10 months (throughout the study period)
Secondary	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)
Secondary	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)
Secondary	Hemodynamic instability	The patients were classified as hemodynamic instability if received vasopressors or ionotropes	10 months (throughout the study period)
Secondary	Delirium after extubation	All patients in the study were routinely screened for delirium using the CAM-ICU score	10 months (throughout the study period)