TraumaNCT00527098
Optimal Fluid Resuscitation for Trauma Patients
An observational study of Trauma, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trauma
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jul 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Trauma Patients
Who may be able to join
- 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
Who cannot join
- Less than 18 or greater than 65 years old
- Pregnant or lactating
- No fluid resuscitation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Trauma
- Keywords
- Trauma Resuscitation
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: From hospital arrival up to an average of 3.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Proctor, University of Miami
- Investigators
- Kenneth G Proctor, PhD, Principal investigator, University of MiamiCarl I Schulman, MD, MSPH, Study director, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527098
- Sponsor's protocol ID
- 20070108
- Status last verified
- Feb 2013
- First submitted
- 6 Sep 2007
- Last updated
- 22 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Earle SA, de Moya MA, Zuccarelli JE, Norenberg MD, Proctor KG. Cerebrovascular resuscitation after polytrauma and fluid restriction. J Am Coll Surg. 2007 Feb;204(2):261-75. doi: 10.1016/j.jamcollsurg.2006.11.014.
PubMed 17254930Crookes BA, Cohn SM, Bonet H, Burton EA, Nelson J, Majetschak M, Varon AJ, Linden JM, Proctor KG. Building a better fluid for emergency resuscitation of traumatic brain injury. J Trauma. 2004 Sep;57(3):547-54. doi: 10.1097/01.ta.0000135162.85859.4c.
PubMed 15454801King DR, Cohn SM, Proctor KG. Changes in intracranial pressure, coagulation, and neurologic outcome after resuscitation from experimental traumatic brain injury with hetastarch. Surgery. 2004 Aug;136(2):355-63. doi: 10.1016/j.surg.2004.05.011.
PubMed 15300202Kelly ME, Miller PR, Greenhaw JJ, Fabian TC, Proctor KG. Novel resuscitation strategy for pulmonary contusion after severe chest trauma. J Trauma. 2003 Jul;55(1):94-105. doi: 10.1097/01.TA.0000029042.37577.A6.
PubMed 12855887
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Fluid Resuscitation for Trauma Patients
- ClinicalTrials.gov ID
- NCT00527098
- Acronym / sponsor ID
- 20070108
- Conditions
- Trauma
- Keywords
- Trauma Resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Posted 4 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Trauma Patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Less than 18 or greater than 65 years old
- Pregnant or lactating
- No fluid resuscitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: From hospital arrival up to an average of 3.5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17254930Earle SA, de Moya MA, Zuccarelli JE, Norenberg MD, Proctor KG. Cerebrovascular resuscitation after polytrauma and fluid restriction. J Am Coll Surg. 2007 Feb;204(2):261-75. doi: 10.1016/j.jamcollsurg.2006.11.014.
- Background: PubMed 15454801Crookes BA, Cohn SM, Bonet H, Burton EA, Nelson J, Majetschak M, Varon AJ, Linden JM, Proctor KG. Building a better fluid for emergency resuscitation of traumatic brain injury. J Trauma. 2004 Sep;57(3):547-54. doi: 10.1097/01.ta.0000135162.85859.4c.
- Background: PubMed 15300202King DR, Cohn SM, Proctor KG. Changes in intracranial pressure, coagulation, and neurologic outcome after resuscitation from experimental traumatic brain injury with hetastarch. Surgery. 2004 Aug;136(2):355-63. doi: 10.1016/j.surg.2004.05.011.
- Background: PubMed 12855887Kelly ME, Miller PR, Greenhaw JJ, Fabian TC, Proctor KG. Novel resuscitation strategy for pulmonary contusion after severe chest trauma. J Trauma. 2003 Jul;55(1):94-105. doi: 10.1097/01.TA.0000029042.37577.A6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth G Proctor, PhD principal investigator
University of Miami
Carl I Schulman, MD, MSPH study director
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: From hospital arrival up to an average of 3.5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00527098, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2013.