Trial Outcomes & Findings for Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy (NCT NCT01239680)

Results Overview

Biological response as characterized by selected cytokines, specifically tumor necrosis factor alpha (TNFα), interleukin one (IL-1β), and interleukin six (IL-6). These are measured using ELISA. Baseline values are expected to be either unobtainable, or in any case less than 50 picograms/ml. If there is a significant inflammatory response, values at 24 hours should be more than 100 picograms/ml for TNFα, IL-1β, and IL-6. Our hypothesis is that there will be a difference between study and control group patients of at least 50 picograms/ml in the levels of these cytokines at 24 hours. Cytokine response is quite variable, and the percentage of outliers (with no cytokine response) in either group may be as high as 50%. .

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Change from Baseline in Cytokine Levels at 24 hours

Results posted on

2014-06-17

Participant Flow

Recruitment period started 01/12/2011. Recruitment ended 11/01/2013. Subjects were recruited from the Emergency Department and Intensive Care Units at Truman Medical Center Hospital Hill. These subjects were Trauma Activations. Recruitment was performed by the Principal Investigator, Research Coordinator, or other approved study staff.

Participant milestones

Participant milestones
Measure	Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate Intravenous 1 liter once over 6 hours	Glutamine: Intravenous 25 Grams Once Over 6 Hours Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours
Overall Study STARTED	3	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate Intravenous 1 liter once over 6 hours	Glutamine: Intravenous 25 Grams Once Over 6 Hours Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours n=3 Participants Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours	Glutamine: Intravenous 25 Grams Once Over 6 Hours n=2 Participants Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours	Total n=5 Participants Total of all reporting groups
Age, Customized Age 21-65	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline in Cytokine Levels at 24 hours

Population: The number of participants who had an intervention and completed the study with all 3 required blood draws.

Biological response as characterized by selected cytokines, specifically tumor necrosis factor alpha (TNFα), interleukin one (IL-1β), and interleukin six (IL-6). These are measured using ELISA. Baseline values are expected to be either unobtainable, or in any case less than 50 picograms/ml. If there is a significant inflammatory response, values at 24 hours should be more than 100 picograms/ml for TNFα, IL-1β, and IL-6. Our hypothesis is that there will be a difference between study and control group patients of at least 50 picograms/ml in the levels of these cytokines at 24 hours. Cytokine response is quite variable, and the percentage of outliers (with no cytokine response) in either group may be as high as 50%. .

Outcome measures

Outcome data not reported

Adverse Events

Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Glutamine: Intravenous 25 Grams Once Over 6 Hours

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

Charles W. Van Way, III, M.D.

Truman Medical Center

Phone: 816.235.2553

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place