Ketamine Infusion as Sedative Analgesic in Severe ARDS (KISS)

• ClinicalTrials.gov Identifier: NCT04818827
• Recruitment Status: Completed
• First Posted: March 26, 2021
• Last Update Posted: March 26, 2021
• Sponsor: Interfaith Medical Center
• Information provided by (Responsible Party): Ramakanth Pata, Interfaith Medical Center

Tracking Information

• First Submitted Date: March 19, 2021
• First Posted Date: March 26, 2021
• Last Update Posted Date: March 26, 2021
• Actual Study Start Date: February 1, 2020
• Actual Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 23, 2021)

All-Cause mortality [ Time Frame: 10 months (throughout the study period) ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 23, 2021)

• Hospital length of stay [ Time Frame: 10 months (throughout the study period) ]
  The two groups were compared for hospital length of stay
• Duration of ventilator days [ Time Frame: 10 months (throughout the study period) ]
  The patients in two groups were compared for the duration of ventilator days
• Infectious complications [ Time Frame: 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
• Acute Kidney Injury [ Time Frame: 10 months (throughout the study period) ]
  Routine blood samples were obtained that included serum creatinine. Acute kidney injury is defined as per KDIGO
• Hemodynamic instability [ Time Frame: 10 months (throughout the study period) ]
  The patients were classified as hemodynamic instability if received vasopressors or ionotropes
• Delirium after extubation [ Time Frame: 10 months (throughout the study period) ]
  All patients in the study were routinely screened for delirium using the CAM-ICU score

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ketamine Infusion as Sedative Analgesic in Severe ARDS
• Official Title: Ketamine Infusion as Sedative Analgesic in Severe ARDS on Mechanically Ventilated Patients
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

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

• Intervention: Not Provided

Study Groups/Cohorts

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 23, 2021): 124
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 14, 2021
• Actual Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04818827
• Other Study ID Numbers: KISS 1.0
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

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

• Current Responsible Party: Ramakanth Pata, Interfaith Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Interfaith Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: RAMAKANTH PATA, MD; Interfaith Medical Center

• PRS Account: Interfaith Medical Center
• Verification Date: March 2021