InjuriesEarly Phase 1NCT00420407

Low Dose Vasopressin in Traumatic Shock

A Early Phase 1 study testing vasopressin in people with Injuries and Shock, Traumatic, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Hypothesis: We hypothesize that resuscitation regimens which minimize the total volume of resuscitation fluid, while restoring organ perfusion, will lead to lower morbidity and mortality in critically ill patients following trauma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Injuries, Shock, Traumatic
What is being tested?: vasopressin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 81 participants
Where: 1 siteUnited States
Study dates: Feb 2007to Feb 2011
Phase: Early Phase 1
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

To be eligible for enrollment in the study, a patient must meet all of the follow criteria at assessment:
Patient is a male or female patient presumed to be at least 18 years of age;
Patient has a systolic blood pressure < 90 mmHg;
Patient has clinical evidence of acute traumatic injury;
Infusion of study drug must start within one hour following SBP (systolic blood pressure) < 90 mmHg

Who cannot join

A patient meeting any one of the following criteria at hospital assessment is not eligible for enrollment:
Patient is admitted to one of the study hospitals' Emergency Department greater than six hours after injury;
Patient has received greater than 4 liters fluid since time of injury;
Patient is enrolled in another shock trial;
Patient is asystolic or requires CPR (cardiopulmonary resucitation) prior to randomization;
Female patient is pregnant by report or suspicion;
Patient has known "Do Not Resuscitate" orders or visible/identifiable method of objection to participation (e.g., exclusion bracelet);

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Prospective, Randomized, Double-Blind, Multi-Center Trial of Low Dose Vasopressin Versus Placebo in Traumatic Shock Resuscitation

Conditions: Injuries, Shock, Traumatic
Being tested: normal saline control, vasopressin
Medical subject headings: Wounds and Injuries, Shock, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

normal saline controlDrug
no vasopressin added to bolus or 5 hour continuous infusion
vasopressinDrug
vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours

Study groups in NCT00420407
Study group	Role	What they receive
I	Experimental	Vasopressin Receives: Drug: vasopressin
2	Placebo comparator	bolus of NS (normal saline) followed by continuous infusion of NS, no vasopressin added Receives: Drug: normal saline control

What is being measured

The primary outcome is the main question the study is designed to answer.

The Primary Endpoint of This Study Will be Day 30 Mortality.
Survival of a traumatic injury subject to at least 30 days after admission to the emergency room.
Measured: 30 days

Secondary outcomes (1)

Level of Vasopressin After Trauma.
Level of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm
Measured: 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Feb 2011

First posted11 Jan 2007 (estimated)
Study startFeb 2007
Primary completionApr 2009
Study completionFeb 2011

Why it stopped: accrual rate

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 (1)Papers the sponsor has linked to this study.
Other trials for InjuriesStudies 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: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00420407
Sponsor's protocol ID: 056-1502-090
Status last verified: Apr 2013
First submitted: 9 Jan 2007
Last updated: 18 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Cohn SM, McCarthy J, Stewart RM, Jonas RB, Dent DL, Michalek JE. Impact of low-dose vasopressin on trauma outcome: prospective randomized study. World J Surg. 2011 Feb;35(2):430-9. doi: 10.1007/s00268-010-0875-8.
PubMed 21161222

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Randomized, Double-Blind, Multi-Center Trial of Low Dose Vasopressin Versus Placebo in Traumatic Shock Resuscitation
ClinicalTrials.gov ID: NCT00420407
Acronym / sponsor ID: 056-1502-090
Conditions: Injuries, Shock, Traumatic
Phase: Early Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: accrual rate
Enrolment: 81 participants (actual)
Lead sponsor: The University of Texas Health Science Center at San AntonioUniversity, hospital or other
Study start: Feb 2007
Primary completion: Apr 2009 (actual)
Study completion: Feb 2011 (actual)
First posted: 11 Jan 2007 (estimated)
Results: Posted 16 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
I	Experimental	Drug: vasopressinVasopressin
2	Placebo comparator	Drug: normal saline controlbolus of NS (normal saline) followed by continuous infusion of NS, no vasopressin added

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

To be eligible for enrollment in the study, a patient must meet all of the follow criteria at assessment:
Patient is a male or female patient presumed to be at least 18 years of age;
Patient has a systolic blood pressure < 90 mmHg;
Patient has clinical evidence of acute traumatic injury;
Infusion of study drug must start within one hour following SBP (systolic blood pressure) < 90 mmHg

Key exclusion criteria (7 listed)

A patient meeting any one of the following criteria at hospital assessment is not eligible for enrollment:
Patient is admitted to one of the study hospitals' Emergency Department greater than six hours after injury;
Patient has received greater than 4 liters fluid since time of injury;
Patient is enrolled in another shock trial;
Patient is asystolic or requires CPR (cardiopulmonary resucitation) prior to randomization;

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
normal saline controlno vasopressin added to bolus or 5 hour continuous infusion	Drug	2
vasopressinvasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours	Drug	I

Primary outcome

The Primary Endpoint of This Study Will be Day 30 Mortality.
Time frame: 30 days
Survival of a traumatic injury subject to at least 30 days after admission to the emergency room.

1 secondary outcome

Level of Vasopressin After Trauma.
Time frame: 12 hours

Results and safety

Results posted to the registry on 16 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal Saline	41	37
Vasopressin	40	34

Primary outcome: The Primary Endpoint of This Study Will be Day 30 Mortality.

Time frame: 30 days. Number. Unit: Participants

Measure	Normal Saline n = 37	Vasopressin n = 34
Value	11	13

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Saline	19 of 41 (46.3%)	37 of 41 (90.2%)	Not reported
Vasopressin	20 of 40 (50%)	35 of 40 (87.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21161222Cohn SM, McCarthy J, Stewart RM, Jonas RB, Dent DL, Michalek JE. Impact of low-dose vasopressin on trauma outcome: prospective randomized study. World J Surg. 2011 Feb;35(2):430-9. doi: 10.1007/s00268-010-0875-8.
Department of Surgery Web Page, Vasopressin presentationLink provided by the sponsor.

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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?

A Early Phase 1 study testing vasopressin in people with Injuries and Shock, Traumatic, 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 Jun 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2013). 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?

The Primary Endpoint of This Study Will be Day 30 Mortality. (time frame: 30 days). 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 NCT00420407, which also lists 1 linked publication.

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 18 Jun 2019.