Trial Outcomes & Findings for Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Ketamine (NCT NCT03621085)

Last Updated: 2021-11-26

Results Overview

Tolerance to a simulated hemorrhagic challenge will be assessed, for both the placebo and ketamine limbs, by causing progressive central hypovolemia via lower-body negative pressure (LBNP). This progressive lower-body negative pressure challenge will be performed until the onset of syncopal symptoms (defined as: profound bradycardia, a precipitous drop in arterial blood pressure and accompanying narrowing of pulse pressure, a sustained systolic blood pressure less than 80 mmHg, and/or subjective symptoms such as light-headedness, sweating, nausea, or dizziness). The primary variable will be the quantification of lower-body negative pressure that is required to cause these symptoms. This quantification will be objectively measured via a cumulative stress index which is calculated as the sum of the product of the LBNP level and the duration of each level, until test termination (i.e., 40 mmHg x 3 min + 50 mmHg x 3 min, etc).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

43 participants

Primary outcome timeframe

12 month

Results posted on

2021-11-26

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine First, Then Placebo Ketamine visit (20 mg) first, then Placebo visit (saline)	Placebo First, Then Ketamine Placebo visit (saline) first, then Ketamine visit (20 mg)
Enrollment STARTED	22	21
Enrollment COMPLETED	16	14
Enrollment NOT COMPLETED	6	7
First Visit STARTED	16	14
First Visit COMPLETED	16	14
First Visit NOT COMPLETED	0	0
Washout (at Least 48 Hours) STARTED	16	14
Washout (at Least 48 Hours) COMPLETED	16	14
Washout (at Least 48 Hours) NOT COMPLETED	0	0
Second Visit STARTED	16	14
Second Visit COMPLETED	16	14
Second Visit NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Ketamine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=43 Participants All participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 month

Outcome measures

Outcome measures
Measure	Ketamine n=30 Participants Subjects will receive up to 20 mg Ketamine Hydrochloride while the effects of this drug on tolerance to a hemorrhagic insult will be assessed. Ketamine Hydrochloride: A total of 20 mg of Ketamine Hydrochloride will be administered intravenously	Placebo n=30 Participants Subjects will receive placebo while the effects of this drug on tolerance to a hemorrhagic insult will be assessed. Placebo: Subjects will receive placebo
Cumulative Stress Index	635 mmHg x minutes Standard Deviation 391	649 mmHg x minutes Standard Deviation 362

SECONDARY outcome

Timeframe: 12 months

Population: Pressure pain tolerance was evaluated in a subset of individuals

Pain assessments will be conducted using a digital algometer to obtain maximum pain thresholds caused by pressure. This pain assessment technique is conducted by applying the tip of a hand-held digital algometer on the subject's digit. Force is gradually increased and the peak force is recorded when the subject first reports a painful sensation. Removal of the pressure from the algometer immediately relieves the painful sensation and the subject can voluntarily stop the test at any time. This assessment will be performed after the subject has received placebo and ketamine.

Outcome measures

Outcome measures
Measure	Ketamine n=20 Participants Subjects will receive up to 20 mg Ketamine Hydrochloride while the effects of this drug on tolerance to a hemorrhagic insult will be assessed. Ketamine Hydrochloride: A total of 20 mg of Ketamine Hydrochloride will be administered intravenously	Placebo n=20 Participants Subjects will receive placebo while the effects of this drug on tolerance to a hemorrhagic insult will be assessed. Placebo: Subjects will receive placebo
Pressure Pain Tolerance	3.3 Kilograms Standard Deviation 1.0	1.6 Kilograms Standard Deviation 0.6

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Craig Crandall

University of Texas Southwestern Medical Center

Phone: 2143454623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place