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Comparator: Ketamine Group for Post-Traumatic Stress Disorder (RSI-LTO Trial)

N/A
Recruiting
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Enrolled in RSI trial (NCT05277896)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

RSI-LTO Trial Summary

The RSI-LTO study collects long-term outcomes from the RSI trial (NCT05277896). One-third of adults who are intubated in the ED or ICU experience symptoms of posttraumatic stress disorder (PTSD). PTSD is a psychiatric disorder triggered by a "shocking, scary, or dangerous event." Critical illness, tracheal intubation, and mechanical ventilation can be traumatic and distressing events. Patients may recall the intubation procedure, the feeling of the breathing tube in their throat, or being unable to move ("paralyzed"). While on the breathing machine, patients may experience delirium, frightening hallucinations, and delusions. Patients with PTSD after critical illness can be hypervigilant, anxious, and troubled by intrusive thoughts, nightmares, and flashbacks that last months to years after critical illness and that PTSD negatively impacts patients' marriages, work, and quality of life and increases patients' risk of depression, anxiety, substance use disorder, and suicide. Ketamine may prevent PTSD symptoms by blocking the pathways in the brain's glutaminergic system that are responsible for the formation of traumatic memories In outpatients with chronic PTSD, a single dose of ketamine has been shown to reduce PTSD symptoms for up to 2 weeks. Even a modest reduction in PTSD would translate into tens of thousands of fewer cases of PTSD each year, more cases of PTSD each year than any other medical intervention evaluated to date.

Eligible Conditions
  • Post-Traumatic Stress Disorder
  • Acute Respiratory Failure

RSI-LTO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

RSI-LTO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PTSD Symptoms at 12 months
Other outcome measures
Anxiety
Awareness of paralysis
Depression
+8 more

RSI-LTO Trial Design

2Treatment groups
Experimental Treatment
Group I: Comparator: Ketamine GroupExperimental Treatment1 Intervention
Intravenous ketamine as the sedative for induction of anesthesia during emergency tracheal intubation.
Group II: Comparator: Etomidate GroupExperimental Treatment1 Intervention
Intravenous etomidate as the sedative for induction of anesthesia during emergency tracheal intubation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1090
Etomidate
2013
Completed Phase 4
~5870

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
670,441 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
550 Previous Clinical Trials
29,995,192 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1003 spots leftby Jan 2027