Trial Outcomes & Findings for The Effect of Ketamine on the Length of Hospital Stay of Patients Hospitalized With Suicidal Ideation. (NCT NCT02997722)
NCT ID: NCT02997722
Last Updated: 2020-06-02
Results Overview
We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
4 participants
Primary outcome timeframe
The dates and times of each patients' admission to and discharge from the inpatient unit (i.e., the data necessary to calculate length of stay) were collected by chart review performed approximately 6 months after enrollment in the study.
Results posted on
2020-06-02
Participant Flow
Participant milestones
| Measure |
Ketamine Infusion
Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.
Ketamine: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.
|
Normal Saline Infusion
Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.
Normal Saline: IV infusion of 100 ml of normal saline over 45 minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ketamine Infusion
n=3 Participants
Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.
Ketamine: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.
|
Normal Saline Infusion
n=1 Participants
Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.
Normal Saline: IV infusion of 100 ml of normal saline over 45 minutes.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
1 Participants
n=1 Participants
|
4 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
47.67 years
n=3 Participants
|
36 years
n=1 Participants
|
44.75 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=3 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=4 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
1 participants
n=1 Participants
|
4 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: The dates and times of each patients' admission to and discharge from the inpatient unit (i.e., the data necessary to calculate length of stay) were collected by chart review performed approximately 6 months after enrollment in the study.We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient.
Outcome measures
| Measure |
Ketamine Infusion
n=3 Participants
Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.
Ketamine: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.
|
Normal Saline Infusion
n=1 Participants
Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.
Normal Saline: IV infusion of 100 ml of normal saline over 45 minutes.
|
|---|---|---|
|
Inpatient Hospital Length of Stay
|
130.75 hours
Interval 62.47 to 227.23
|
81.97 hours
Interval 81.97 to 81.97
|
Adverse Events
Ketamine Infusion
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Normal Saline Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine Infusion
n=3 participants at risk
Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.
Ketamine: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.
|
Normal Saline Infusion
n=1 participants at risk
Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.
Normal Saline: IV infusion of 100 ml of normal saline over 45 minutes.
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
33.3%
1/3 • Number of events 1 • We recorded adverse events that occurred during the infusion and for 30 minutes after the infusion.
|
0.00%
0/1 • We recorded adverse events that occurred during the infusion and for 30 minutes after the infusion.
|
|
Gastrointestinal disorders
vomiting
|
33.3%
1/3 • Number of events 1 • We recorded adverse events that occurred during the infusion and for 30 minutes after the infusion.
|
0.00%
0/1 • We recorded adverse events that occurred during the infusion and for 30 minutes after the infusion.
|
Additional Information
Allen Richert, MD
University of Mississippi Medical Center
Phone: (601) 984-4820
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place