Body Response to TraumaNCT01107314
Vasopressin Deficiency in Hemorrhagic Shock
An observational study of Body Response to Trauma, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
In this study we hope to delineate the typical vasoactive mediator response of trauma patients to shock. We plan to assess serum levels of vasopressin and also catecholamines, angiotensin, and cortisol during resuscitation of trauma patients to delineate high risk populations for vasopressin deficiency. Read more about this study
- Who is it for?
- Ages 18 to 98 years
- Conditions the study is for
- Body Response to Trauma
- What is being tested?
- Phlebotomy
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to 30 Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 98 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: observational study - trauma patients admitted to University Hospital
Who may be able to join
- Patient is a male or female patient presumed to be at least 18 years of age;
- Patient has a reported or actual systolic blood pressure < 90 mmHg within 1 hour of arrival to the Emergency Room;
- Patient has clinical evidence of acute traumatic injury;
Who cannot join
- Patient is asystolic or requires CPR prior to arrival;
- Patient was transferred from an outside facility
- Patient known to be pregnant
- Patient known to be prisoner
Trial locations and contacts
1 site in 1 country.
About this study
In this study we hope to delineate the typical vasoactive mediator response of trauma patients to shock. We plan to assess serum levels of vasopressin and also catecholamines, angiotensin, and cortisol during resuscitation of trauma patients to delineate high risk populations for vasopressin deficiency.
Read the detailed description
This is a prospective observational study. The only research-driven procedure will be the removal of blood samples at designated time points(total blood removed 48 cc per patient). Hemodynamic, fluid infusion and agitation/pain data (RAMSEY Score) will prospectively be collected for research purposes. We will collect data from a convenience sample of patients (when research staff is available) over a one year period.
- Conditions
- Body Response to Trauma
- Being tested
- Phlebotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhlebotomyOther
Blood draws (total 48 cc blood)
| Study group | Role | What they receive |
|---|---|---|
| trauma patient | SBP less than 90mmHg Receives: Other: Phlebotomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completion30 Apr 2011
- Study completion30 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Response to TraumaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen M Cohn, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107314
- Sponsor's protocol ID
- 2009-0528-H
- Other IDs
- A-13969.2
- Status last verified
- Mar 2012
- First submitted
- 19 Apr 2010
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasopressin Deficiency in Hemorrhagic Shock
- ClinicalTrials.gov ID
- NCT01107314
- Acronym / sponsor ID
- 2009-0528-H
- Conditions
- Body Response to Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- 30 Apr 2011 (actual)
- Study completion
- 30 Apr 2011 (actual)
- First posted
- 20 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study we hope to delineate the typical vasoactive mediator response of trauma patients to shock. We plan to assess serum levels of vasopressin and also catecholamines, angiotensin, and cortisol during resuscitation of trauma patients to delineate high risk populations for vasopressin deficiency.
Detailed description
This is a prospective observational study. The only research-driven procedure will be the removal of blood samples at designated time points(total blood removed 48 cc per patient). Hemodynamic, fluid infusion and agitation/pain data (RAMSEY Score) will prospectively be collected for research purposes. We will collect data from a convenience sample of patients (when research staff is available) over a one year period.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trauma patient | – | Other: PhlebotomySBP less than 90mmHg |
Who may qualify
- Ages
- 18 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- observational study - trauma patients admitted to University Hospital
Key inclusion criteria (3 listed)
- Patient is a male or female patient presumed to be at least 18 years of age;
- Patient has a reported or actual systolic blood pressure < 90 mmHg within 1 hour of arrival to the Emergency Room;
- Patient has clinical evidence of acute traumatic injury;
Key exclusion criteria (4 listed)
- Patient is asystolic or requires CPR prior to arrival;
- Patient was transferred from an outside facility
- Patient known to be pregnant
- Patient known to be prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhlebotomyBlood draws (total 48 cc blood) | Other | trauma patient |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
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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.
Stephen M Cohn, MD principal investigator
The University of Texas Health Science Center at San Antonio
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 Body Response to Trauma, run by The University of Texas Health Science Center at San Antonio 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 4 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 17 Jan 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 17 Jan 2018.