Ketamine Infusion as Sedative Analgesic in Severe ARDS

NCT ID: NCT04818827

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 124 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2021-02-14

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Ketamine group

This cohort includes patients who received ketamine as a sedative analgesic agent during mechanical ventilation

No interventions assigned to this group

Non Ketamine group

This cohort includes patients who received sedatives other than ketamine during mechanical ventilation

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Interfaith Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ramakanth Pata

Pulmonary Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

RAMAKANTH PATA, MD

Role: PRINCIPAL_INVESTIGATOR

Interfaith Medical Center

Locations

Interfaith Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

KISS 1.0

Identifier Type: -

Identifier Source: org_study_id