An Early Phase 1 interventional study of normal saline control and vasopressin in Injuries and Shock, Traumatic, sponsored by The University of Texas Health Science Center at San Antonio. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-18.
Sponsored by The University of Texas Health Science Center at San Antonio · Early Phase 1, Interventional, and Treatment
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.
5,085 studies on the registry are indexed under Wounds and Injuries; 849 are open to participants now.
This study's enrollment of 81 is above the median of 52 across 3,261 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 443 studies on the registry; 88 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 35 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible for enrollment in the study, a patient must meet all of the follow criteria at assessment:
Exclusion Criteria:
A patient meeting any one of the following criteria at hospital assessment is not eligible for enrollment:
Vasopressin
Drug: vasopressin
bolus of NS (normal saline) followed by continuous infusion of NS, no vasopressin added
Drug: normal saline control
no vasopressin added to bolus or 5 hour continuous infusion
vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
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.
Time frame: 30 days
Level of Vasopressin After Trauma.
Level of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm
Time frame: 12 hours
recruitment location - Emergency room Feb 2007- Feb 2009
| Milestone | Normal Saline | Vasopressin |
|---|---|---|
| Started | 41 | 40 |
| Completed | 37 | 34 |
| Not completed | 4 | 6 |
| Withdrew: Lost to follow-up | 0 | 3 |
| Withdrew: Physician decision | 2 | 1 |
| Withdrew: Subject identified as detainee | 1 | 0 |
| Withdrew: Subject identified as jehovah's witness | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 |
Survival of a traumatic injury subject to at least 30 days after admission to the emergency room.
| Participants | Normal Saline | Vasopressin |
|---|---|---|
| The Primary Endpoint of This Study Will be Day 30 Mortality. | 11 | 13 |
Level of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm
| pg/ml | Evaluation of Vasopressin Level Following Trauma |
|---|---|
| Level of Vasopressin After Trauma. | 25 ± 37 |
Collected over Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Normal Saline | — | 19/41 (46.3%) | 37/41 (90.2%) |
| Vasopressin | — | 20/40 (50%) | 35/40 (87.5%) |
| Event | Normal Saline | Vasopressin |
|---|---|---|
| Multiple Organ FailureGeneral disorders | 2/41 | 4/40 |
| Traumatic Brain Injury (TBI)Nervous system disorders | 3/41 | 4/40 |
| Cardiopulmonary ArrestGeneral disorders | 4/41 | 3/40 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 4/41 | 3/40 |
| Hemorrhagic ShockGeneral disorders | 1/41 | 3/40 |
| Deep Vein ThrombosisVascular disorders | 0/41 | 3/40 |
| Multisystem TraumaGeneral disorders | 3/41 | 0/40 |
| HypertensonCardiac disorders | 0/41 | 2/40 |
| Cardiac ArrhythmiaCardiac disorders | 1/41 | 2/40 |
| Acute Respiratory Distress Syndrome (ARDS)Respiratory, thoracic and mediastinal disorders | 1/41 | 2/40 |
| Event | Normal Saline | Vasopressin |
|---|---|---|
| HyperglycemiaEndocrine disorders | 9/41 | 6/40 |
| Skin BreakdownSkin and subcutaneous tissue disorders | 3/41 | 8/40 |
| HypophosphatemiaEndocrine disorders | 7/41 | 2/40 |
| ConstipationGastrointestinal disorders | 6/41 | 5/40 |
| Multiorgan failureGeneral disorders | 6/41 | 3/40 |
| AnemiaBlood and lymphatic system disorders | 3/41 | 5/40 |
| HypocalcemiaEndocrine disorders | 5/41 | 3/40 |
| HypokalemiaEndocrine disorders | 5/41 | 4/40 |
| insomiaNervous system disorders | 5/41 | 1/40 |
| Pleural EffusionsRespiratory, thoracic and mediastinal disorders | 5/41 | 1/40 |
Vasopressin enrolled 40 and two withdrawn and never received drug (38) Normal saline enrolled 41 and one withdrawn and never received drug (40)
| Age, Categorical(Participants) | Normal Saline | Vasopressin | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 35 | 35 | 70 |
| >=65 years | 6 | 5 | 11 |
| Age, Continuous(years) | Normal Saline | Vasopressin | Total |
|---|---|---|---|
| Mean | 46.3 ± 26.1 | 48.1 ± 19.8 | 47.1 ± 20.4 |
| Sex: Female, Male(Participants) | Normal Saline | Vasopressin | Total |
|---|---|---|---|
| Female | 7 | 11 | 18 |
| Male | 34 | 29 | 63 |
| Region of Enrollment(participants) | Normal Saline | Vasopressin | Total |
|---|---|---|---|
| United States | 41 | 40 | 81 |
This study is terminated, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Arginine Vasopressin
The University of Texas Health Science Center at San Antonio →