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accrual rate
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | Vasopressin |
|
| 2 | Placebo Comparator | bolus of NS (normal saline) followed by continuous infusion of NS, no vasopressin added |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normal saline control | Drug | no vasopressin added to bolus or 5 hour continuous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Vasopressin After Trauma. | Level of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm | 12 hours |
Not provided
Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen M. Cohn, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21161222 | Result | 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. |
| Label | URL |
|---|---|
| Department of Surgery Web Page, Vasopressin presentation | View source |
Not provided
clinical indication prohibiting potential use of vasopressin.
recruitment location - Emergency room Feb 2007- Feb 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Saline | bolus of NS (normal saline) followed by continuous infusion of NS, no vasopressin added normal saline control : no vasopressin added to bolus or 5 hour continuous infusion |
| FG001 | Vasopressin | Vasopressin vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Vasopressin enrolled 40 and two withdrawn and never received drug (38) Normal saline enrolled 41 and one withdrawn and never received drug (40)
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Saline | bolus of NS followed by continuous infusion of NS, no vasopressin added normal saline control : no vasopressin added to bolus or 5 hour continuous infusion |
| BG001 | Vasopressin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Participants | 30 days |
|
Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Saline | bolus of NS followed by continuous infusion of NS, no vasopressin added normal saline control : no vasopressin added to bolus or 5 hour continuous infusion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiopulmonary Arrest | General disorders | Non-systematic Assessment | includes cardiac and cardiopulmonay arrest |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Cohn, M.D. | University of Texas Health Science Center at San Antonio | 210-567-5724 | mccarthyj@uthscsa.edu |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D012774 | Shock, Traumatic |
| ID | Term |
|---|---|
| D012769 | Shock |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014667 | Vasopressins |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| vasopressin |
| Drug |
vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours |
|
| subject identified as detainee |
|
| subject identified as Jehovah's witness |
|
| Withdrawal by Subject |
|
Vasopressin
vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Level of Vasopressin After Trauma. | Level of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm | Posted | Mean | Standard Deviation | pg/ml | 12 hours |
|
|
|
| 19 |
| 41 |
| 37 |
| 41 |
| EG001 | Vasopressin | Vasopressin vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours | 20 | 40 | 35 | 40 |
|
| Cardiac Dysrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| exsanguination | General disorders | Non-systematic Assessment |
|
| Hemorrhagic Shock | General disorders | Non-systematic Assessment | includes refractory hemorrhagic shock(1) |
|
| Hypertenson | Cardiac disorders | Non-systematic Assessment |
|
| Multisystem Trauma | General disorders | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac Arrhythmia | Cardiac disorders | Non-systematic Assessment | Pulseless electrical activity, pulseless ventricular tachycardia, supraventricular tachycardia, intermittent |
|
| reperfusion syndrome | Vascular disorders | Non-systematic Assessment |
|
| Ogilvies Syndrome | Gastrointestinal disorders | Non-systematic Assessment |
|
| Upper GI bleed | Gastrointestinal disorders | Non-systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | Non-systematic Assessment | locations - Femoral, popliteal, subclavian |
|
| Heparin induced thrombocytopenia | Vascular disorders | Non-systematic Assessment |
|
| Sepsis, abdominal | General disorders | Non-systematic Assessment |
|
| Dehiscence, wound | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Systemic Inflamatory Response Syndrome (SIRS) | General disorders | Non-systematic Assessment |
|
| Ischemic Necrosis Bilateral Lower Extremities | Vascular disorders | Non-systematic Assessment |
|
| Bacterial Meningitis | General disorders | Non-systematic Assessment |
|
| Cellutlitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Shock, Septic | General disorders | Non-systematic Assessment |
|
| Multiple Organ Failure | General disorders | Non-systematic Assessment | includes multiple organ dysfunction. |
|
| Compartment Syndrome | Vascular disorders | Non-systematic Assessment |
|
| Traumatic Brain Injury (TBI) | Nervous system disorders | Non-systematic Assessment | nonsurvivable TBI |
|
| Acute Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Empyema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary Emboli | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | included pulmonary embolis and embolism |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Retroperitoneal bleed | General disorders | Non-systematic Assessment |
|
| Pulmonary Hemorrhage | General disorders | Non-systematic Assessment |
|
| Renal Insufficiency, worsening | Renal and urinary disorders | Non-systematic Assessment |
|
| Candidemia | Infections and infestations | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | Non-systematic Assessment |
|
| Hypoperfusion | Cardiac disorders | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Adrenal Insufficiency | Endocrine disorders | Non-systematic Assessment |
|
| Diabetes Insipidus | Endocrine disorders | Non-systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | Non-systematic Assessment | included intermittent Hyperglycemia |
|
| hypoglycemia | Endocrine disorders | Non-systematic Assessment | includes intermittent hypoglycemia |
|
| Hyperphosphatemia | Endocrine disorders | Non-systematic Assessment |
|
| Hypocalcemia | Endocrine disorders | Non-systematic Assessment | includes intermittent hypocalcemia |
|
| Hypokalemia | Endocrine disorders | Non-systematic Assessment | includes intermittent hypokalemia |
|
| Hypomagnesemia | Endocrine disorders | Non-systematic Assessment | included intermittent hypomagnesemia |
|
| Hypophosphatemia | Endocrine disorders | Non-systematic Assessment | includes intermittent hypophosphatemia |
|
| Dysphagia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Thrush | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Hypernatremia | Endocrine disorders | Non-systematic Assessment | includes intermittent hypernatremia |
|
| Hyponatremia | Endocrine disorders | Non-systematic Assessment | includes intermittent hyponatermia |
|
| Hyperkalemia | Endocrine disorders | Non-systematic Assessment | includes intermittent hyperkalemia |
|
| Otorrhea | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Acute Choleycystitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bowel Distention | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cholelithiasis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment | includeds intermittent |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Elevated gastric residuals | Gastrointestinal disorders | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Epigastric Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
|
| incontinence stool | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | includes intermittent |
|
| oliguria | Renal and urinary disorders | Non-systematic Assessment | Urinary retention, failur to void |
|
| Incontinence Urine | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Dilitional Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Elevated INR | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Cephalic Vein Thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Elevated Liver Function Tests | Hepatobiliary disorders | Non-systematic Assessment |
|
| Abdominal Infection | Infections and infestations | Non-systematic Assessment |
|
| Bacteremia | Infections and infestations | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Elevated Temperature | Infections and infestations | Non-systematic Assessment |
|
| Postitive blood cultures | Infections and infestations | Non-systematic Assessment |
|
| Wound Infection | Infections and infestations | Non-systematic Assessment |
|
| Skin Breakdown | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hives | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Infiltration, skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Itching, intermittant | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Wound Dehiscence | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Multiorgan failure | General disorders | Non-systematic Assessment | Hepatic/pulmonary |
|
| Rhabdomyolosis | General disorders | Non-systematic Assessment |
|
| Myoglobinuria | General disorders | Non-systematic Assessment |
|
| Edema | Vascular disorders | Non-systematic Assessment | bilateral lower extremity edema |
|
| Agitation | Nervous system disorders | Non-systematic Assessment |
|
| Allergic reaction to enalapril | General disorders | Non-systematic Assessment |
|
| anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Delirium Tremors | Nervous system disorders | Non-systematic Assessment |
|
| Azotemia | Renal and urinary disorders | Non-systematic Assessment |
|
| Elevated Lactic Acid | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hiccups | General disorders | Non-systematic Assessment |
|
| Hyper-reflexia | Nervous system disorders | Non-systematic Assessment |
|
| Hyperthermia | General disorders | Non-systematic Assessment | included intermittent |
|
| insomia | Nervous system disorders | Non-systematic Assessment | included intermittent |
|
| anxiousness | Nervous system disorders | Non-systematic Assessment | intermittent |
|
| Hyperchloremia | Metabolism and nutrition disorders | Non-systematic Assessment | intermittent |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Reflux | Gastrointestinal disorders | Non-systematic Assessment |
|
| acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
|
| Impaired Renal Function | Renal and urinary disorders | Non-systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pleural Effusions | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | unilateral and/or bilateral |
|
| Exacerbation COPD | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hemothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| desaturation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | intermittent |
|
| Laryngeal Edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | includes lung infection |
|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
Not provided
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |