Ketamine Infusion as Sedative Analgesic in Severe ARDS | NCT04818827

Studies
Ketamine Infusion as Sedative Analgesic in Severe ARDS

NCT04818827

Sponsor

Interfaith Medical Center

Status

Completed

Last Update Posted

Mar 26, 2021Actual

Enrollment

124Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2020Actual

Primary Completion Date

Nov 30, 2020Actual

Completion Date

Feb 14, 2021Actual

First Submitted Date

Mar 19, 2021

First Submission Date that Met QC Criteria

Mar 23, 2021

First Posted Date

Mar 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2021

Last Update Posted Date

Mar 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

This study includes patients who are on mechanical ventilators and classified as moderate to severe ARDS with a PF ratio < 150.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
RAMAKANTH PATA, MD	Interfaith Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Interfaith Medical Center		New York	New York	11414	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Willing to share all aspects of de-identified data

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Available from March 30/2021

Access Criteria

Can be accessed via publishing journal

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

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Browse Branches

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