InjuryNCT01676454
Serum Vasopressin Levels and Severe Hemorrhagic Shock
An observational study of Injury, run by Poudre Valley Health System at 1 site in United States.
Trial summary
The purpose of this study is to determine if vasopressin is used up by the body during traumatic shock (severe low blood pressure due to trauma). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injury
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jan 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to Medical Center of the Rockies with minor injuries.
Who may be able to join
- Patients with a minor injury or injuries, defined as:
- no episodes of systolic blood pressure < 90 mmHg between occurrence of injury and admission;
- no blood transfusion requirement;
- base deficit < 5 mEq/L;
- no requirement for mechanical ventilation other than transiently during orthopedic surgery.
Who cannot join
- Pregnancy
- corticosteroid use,
- prisoners, and/or
- head trauma as determined by computed tomography (head trauma may itself induce diabetes insipidus, a marker of pituitary damage and vasopressin deficiency), and/or
- evidence of spinal cord injury (another cause of vasodilatory shock).
- Patients will also be excluded if pre-hospital provider information cannot be obtained, or indicates that the trauma occurred more than one 1 hour prior to emergency department admission.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Center of the Rockies
Loveland, Colorado, 80538
About this study
Official title: Determination of Serum Vasopressin Levels and Correlation With Life-threatening Complications in Adults With Severe Hemorrhagic Shock.
The purpose of this study is to determine if vasopressin is used up by the body during traumatic shock (severe low blood pressure due to trauma).
Read the detailed description
For humans suffering trauma and severe hemorrhagic shock, no randomized controlled studies of the effect of exogenous vasopressin use exist, although case reports have suggested it may be of benefit. Even some moribund patients with "irreversible" shock survived severe hemorrhagic shock after administration of vasopressin. This suggests that at least some patients suffering severe trauma could benefit from AAVP administration. Recently, many clinicians and notable research consortiums have suggested that AVP shows promise for human resuscitation and have called for further human studies.
This is a prospective, single-center observational study designed to evaluate (1) whether vasopressin is depleted in severe, but not minor, trauma; and (2) the degree to which endogenous vasopressin levels predict the occurrence of ARDS, sepsis, or death. To test the first hypothesis, serum vasopressin levels (continuous independent variable) will be assessed at enrollment (time 0), 6, 12, 18, and 24 hours later, and correlated with the two levels of trauma (categorical dependent variable). To test the second hypothesis, serum vasopressin levels (now a continuous dependent variable) will be correlated with each of three outcomes-death, ARDS, and sepsis.
- Conditions
- Injury
- Keywords
- Vasopressin, Trauma, Injury
- Medical subject headings
- Wounds and Injuries, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vasopressin levels. | Cohort will consist of subjects with a minor injury or injuries defined as: 1. no episodes of systolic blood pressure < 90 mmHg between occurrence of injury and admission; 2. no blood transfusion requirement; 3. base deficit < 5 mEq/L; 4. no requirement for mechanical ventilation other than transiently during orthopedic surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum vasopressin levels.
6 mL's per blood draw for 5 timepoints=30 mL's total blood drawn.
Measured: 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Study closed without enrollment .
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poudre Valley Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Dunn, M.D., Poudre Valley Health System
- Investigators
- Julie Dunn, M.D., Principal investigator, Poudre Valley Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676454
- Sponsor's protocol ID
- Vasopressin Study
- Status last verified
- May 2018
- First submitted
- 21 Aug 2012
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Serum Vasopressin Levels and Correlation With Life-threatening Complications in Adults With Severe Hemorrhagic Shock.
- ClinicalTrials.gov ID
- NCT01676454
- Acronym / sponsor ID
- Vasopressin Study
- Conditions
- Injury
- Keywords
- Vasopressin, Trauma, Injury
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study closed without enrollment .
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Poudre Valley Health SystemUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 31 Aug 2012 (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.
The purpose of this study is to determine if vasopressin is used up by the body during traumatic shock (severe low blood pressure due to trauma).
Detailed description
For humans suffering trauma and severe hemorrhagic shock, no randomized controlled studies of the effect of exogenous vasopressin use exist, although case reports have suggested it may be of benefit. Even some moribund patients with "irreversible" shock survived severe hemorrhagic shock after administration of vasopressin. This suggests that at least some patients suffering severe trauma could benefit from AAVP administration. Recently, many clinicians and notable research consortiums have suggested that AVP shows promise for human resuscitation and have called for further human studies.
This is a prospective, single-center observational study designed to evaluate (1) whether vasopressin is depleted in severe, but not minor, trauma; and (2) the degree to which endogenous vasopressin levels predict the occurrence of ARDS, sepsis, or death. To test the first hypothesis, serum vasopressin levels (continuous independent variable) will be assessed at enrollment (time 0), 6, 12, 18, and 24 hours later, and correlated with the two levels of trauma (categorical dependent variable). To test the second hypothesis, serum vasopressin levels (now a continuous dependent variable) will be correlated with each of three outcomes-death, ARDS, and sepsis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vasopressin levels. | – | –Cohort will consist of subjects with a minor injury or injuries defined as: 1. no episodes of systolic blood pressure < 90 mmHg between occurrence of injury and admission; 2. no blood transfusion requirement; 3. base deficit < 5 mEq/L; 4. no requirement for mechanical ventilation other than transiently during orthopedic surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Medical Center of the Rockies with minor injuries.
Key inclusion criteria (5 listed)
- no episodes of systolic blood pressure < 90 mmHg between occurrence of injury and admission;
- no blood transfusion requirement;
- base deficit < 5 mEq/L;
- no requirement for mechanical ventilation other than transiently during orthopedic surgery.
Key exclusion criteria (6 listed)
- Pregnancy
- corticosteroid use,
- prisoners, and/or
- head trauma as determined by computed tomography (head trauma may itself induce diabetes insipidus, a marker of pituitary damage and vasopressin deficiency), and/or
- evidence of spinal cord injury (another cause of vasodilatory shock).
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
Serum vasopressin levels.
Time frame: 24 hours.
6 mL's per blood draw for 5 timepoints=30 mL's total blood drawn.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- System websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Julie Dunn, M.D. principal investigator
Poudre Valley Health System
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 Injury, run by Poudre Valley Health System 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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 25 May 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 was withdrawn before enrolling participants, so there are no results.
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?
Serum vasopressin levels. (time frame: 24 hours.). It is what the study was designed to measure, not a finding.
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 25 May 2018.