Trauma
Conditions
Keywords
Trauma Resuscitation
Brief summary
The purpose of this study is to determine if the overall fluid requirements for the first 24 hours after admission will be reduced with Hextend versus a standard of care crystalloid resuscitation fluid.
Detailed description
Following severe multi-system traumatic injury, the first 24 hours of standard resuscitation fluid will be either Hextend or crystalloid depending upon attending preference. No tests or interventions will be performed for research purposes. Data will be collected prospectively from patient medical records and attending clinicians to monitor fluid requirements, hemodynamics and outcome.
Interventions
None listed
Sponsors
University of Miami
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Greater than or equal to 18 years old and less than 65 years old * Admission with multi-system traumatic injury * Admission to the intensive care unit
Exclusion criteria
* Less than 18 or greater than 65 years old * Pregnant or lactating * No fluid resuscitation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality | From hospital arrival up to an average of 3.5 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hextend Plus Standard of Care Hextend along with the routine Standard of Care Resuscitation Fluid | 36 |
| Standard of Care Routine Standard of Care Resuscitation Fluid | 83 |
| Total | 119 |
Baseline characteristics
| Characteristic | Standard of Care | Hextend Plus Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 83 Participants | 36 Participants | 119 Participants |
| Age Continuous | 39 years STANDARD_DEVIATION 17 | 39 years STANDARD_DEVIATION 17 | 39 years STANDARD_DEVIATION 17 |
| Region of Enrollment United States | 83 participants | 36 participants | 119 participants |
| Sex: Female, Male Female | 17 Participants | 7 Participants | 24 Participants |
| Sex: Female, Male Male | 66 Participants | 29 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 36 | 0 / 83 |
Outcome results
Primary
Mortality
Time frame: From hospital arrival up to an average of 3.5 weeks
Population: Analysis was per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Observational | Mortality | 0 participants |