Ketamine Infusion as Sedative Analgesic in Severe ARDS

NCT04818827 | Completed

• 1 other identifier: KISS 1.0
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

ketamine; Mechanical ventilation; sedative analgesic; hospital length of stay; Number of ventilator days; mortality

Outcome Measures

Primary Outcomes (1)

• All-Cause mortality

  The two groups were compared for all-cause mortality during the ICU stay

  10 months (throughout the study period)

Secondary Outcomes (6)

• Hospital length of stay

  10 months (throughout the study period)

• Duration of ventilator days

  10 months (throughout the study period)

• Infectious complications

  10 months (throughout the study period)

• Acute Kidney Injury

  10 months (throughout the study period)

• Hemodynamic instability

  10 months (throughout the study period)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• post-cardiac arrest status,
• premorbid diagnosis of dementia,
• dependency on extra-corporeal therapies prior to or during ICU stay

Sponsors & Collaborators

• Interfaith Medical Center: lead

Study Sites (1)

Interfaith Medical Center

New York, New York, 11414, United States

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• RAMAKANTH PATA, MD

  Interfaith Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary Fellow

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 26, 2021
• Study Start: February 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: February 14, 2021
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Available from March 30/2021
• Access Criteria: Can be accessed via publishing journal

Locations

US (1)