Ketamine Infusion as Sedative Analgesic in Severe ARDS (KISS)

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

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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 11414
      • Interfaith Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Ketamine group; This cohort includes patients who received ketamine as a sedative analgesic agent during mechanical ventilation
Non Ketamine group; This cohort includes patients who received sedatives other than ketamine during mechanical ventilation

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Interfaith Medical Center
• Investigators: Principal Investigator: RAMAKANTH PATA, MD, Interfaith Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): February 14, 2021

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 26, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: ketamine; mortality; Mechanical ventilation; sedative analgesic; hospital length of stay; Number of ventilator days
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: KISS 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Willing to share all aspects of de-identified data
• IPD Sharing Time Frame: Available from March 30/2021
• IPD Sharing Access Criteria: Can be accessed via publishing journal
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No