Low Dose Vasopressin in Traumatic Shock

• Sponsor: The University of Texas Health Science Center at San Antonio (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00420407
• Collaborator: (none)
• Enrollment: 81
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Injuries; Shock, Traumatic	Drug: normal saline control; Drug: vasopressin	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Prospective, Randomized, Double-Blind, Multi-Center Trial of Low Dose Vasopressin Versus Placebo in Traumatic Shock Resuscitation
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I Vasopressin	Drug: vasopressin; vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
Placebo Comparator: 2 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

Outcome Measures

Primary Outcome Measures

1. The Primary Endpoint of This Study Will be Day 30 Mortality. [30 days]

   Survival of a traumatic injury subject to at least 30 days after admission to the emergency room.

Secondary Outcome Measures

1. Level of Vasopressin After Trauma. [12 hours]

   Level of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

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);

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• The University of Texas Health Science Center at San Antonio

Investigators

• Principal Investigator: Stephen M. Cohn, MD, The University of Texas Health Science Center at San Antonio

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Department of Surgery Web Page, Vasopressin presentation

Publications

None provided.

• Responsible Party: The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT00420407
• Other Study ID Numbers: 056-1502-090
• First Posted: Jan 11, 2007
• Last Update Posted: Jun 18, 2019
• Last Verified: Apr 1, 2013

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Shock; Shock, Traumatic; Vasopressins; Arginine Vasopressin

Study Results

Participant Flow

Recruitment Details	recruitment location - Emergency room Feb 2007- Feb 2009
Pre-assignment Detail	clinical indication prohibiting potential use of vasopressin.

Arm/Group Title	Normal Saline	Vasopressin
Arm/Group Description	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	Vasopressin vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
Period Title: Overall Study
STARTED	41	40
COMPLETED	37	34
NOT COMPLETED	4	6

Baseline Characteristics

Arm/Group Title	Normal Saline	Vasopressin	Total
Arm/Group Description	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	Vasopressin vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours	Total of all reporting groups
Overall Participants	41	40	81
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	35 85.4%	35 87.5%	70 86.4%
>=65 years	6 14.6%	5 12.5%	11 13.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.3 (26.1)	48.1 (19.8)	47.1 (20.4)
Sex: Female, Male (Count of Participants)
Female	7 17.1%	11 27.5%	18 22.2%
Male	34 82.9%	29 72.5%	63 77.8%
Region of Enrollment (participants) [Number]
United States	41 100%	40 100%	81 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Saline	Vasopressin
Arm/Group Description	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	vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
Measure Participants	37	34
Number [Participants]	11 26.8%	13 32.5%

2. Secondary Outcome

Title	Level of Vasopressin After Trauma.
Description	Level of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm
Time Frame	12 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evaluation of Vasopressin Level Following Trauma
Arm/Group Description	All traumatic subjects that had a blood sample assessed for vasopressin.
Measure Participants	34
Mean (Standard Deviation) [pg/ml]	25 (37)

Adverse Events

Time Frame	Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
Arm/Group Title	Normal Saline		Vasopressin
Arm/Group Description	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		Vasopressin vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
All Cause Mortality
	Normal Saline		Vasopressin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Normal Saline		Vasopressin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/41 (46.3%)		20/40 (50%)
Cardiac disorders
Cardiac Dysrhythmia	0/41 (0%)	0	1/40 (2.5%)	1
Hypertenson	0/41 (0%)	0	2/40 (5%)	2
Myocardial Infarction	0/41 (0%)	0	1/40 (2.5%)	1
Cardiac Arrhythmia	1/41 (2.4%)	1	2/40 (5%)	2
Gastrointestinal disorders
Ogilvies Syndrome	0/41 (0%)	0	1/40 (2.5%)	1
Upper GI bleed	0/41 (0%)	0	1/40 (2.5%)	1
General disorders
Cardiopulmonary Arrest	4/41 (9.8%)	4	3/40 (7.5%)	3
exsanguination	1/41 (2.4%)	1	1/40 (2.5%)	1
Hemorrhagic Shock	1/41 (2.4%)	1	3/40 (7.5%)	3
Multisystem Trauma	3/41 (7.3%)	3	0/40 (0%)	0
Sepsis, abdominal	0/41 (0%)	0	1/40 (2.5%)	1
Systemic Inflamatory Response Syndrome (SIRS)	1/41 (2.4%)	1	0/40 (0%)	0
Bacterial Meningitis	1/41 (2.4%)	1	0/40 (0%)	0
Shock, Septic	1/41 (2.4%)	1	0/40 (0%)	0
Multiple Organ Failure	2/41 (4.9%)	2	4/40 (10%)	4
Retroperitoneal bleed	1/41 (2.4%)	1	0/40 (0%)	0
Pulmonary Hemorrhage	0/41 (0%)	0	1/40 (2.5%)	1
Infections and infestations
Candidemia	1/41 (2.4%)	1	0/40 (0%)	0
Nervous system disorders
Traumatic Brain Injury (TBI)	3/41 (7.3%)	3	4/40 (10%)	4
Renal and urinary disorders
Renal Insufficiency, worsening	0/41 (0%)	0	1/40 (2.5%)	1
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome (ARDS)	1/41 (2.4%)	1	2/40 (5%)	2
Empyema	1/41 (2.4%)	1	0/40 (0%)	0
Pneumonia	4/41 (9.8%)	4	3/40 (7.5%)	3
Pulmonary Emboli	2/41 (4.9%)	2	2/40 (5%)	2
Respiratory Distress	0/41 (0%)	0	2/40 (5%)	2
Skin and subcutaneous tissue disorders
Dehiscence, wound	1/41 (2.4%)	1	0/40 (0%)	0
Cellutlitis	0/41 (0%)	0	1/40 (2.5%)	1
Vascular disorders
reperfusion syndrome	0/41 (0%)	0	1/40 (2.5%)	1
Deep Vein Thrombosis	0/41 (0%)	0	3/40 (7.5%)	3
Heparin induced thrombocytopenia	0/41 (0%)	0	1/40 (2.5%)	1
Ischemic Necrosis Bilateral Lower Extremities	0/41 (0%)	0	1/40 (2.5%)	1
Compartment Syndrome	0/41 (0%)	0	1/40 (2.5%)	1
Other (Not Including Serious) Adverse Events
	Normal Saline		Vasopressin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	37/41 (90.2%)		35/40 (87.5%)
Blood and lymphatic system disorders
Anemia	3/41 (7.3%)	3	5/40 (12.5%)	5
Dilitional Thrombocytopenia	0/41 (0%)	0	1/40 (2.5%)	1
Elevated INR	0/41 (0%)	0	1/40 (2.5%)	1
Leukocytosis	1/41 (2.4%)	1	1/40 (2.5%)	1
Cardiac disorders
Hypotension	2/41 (4.9%)	2	3/40 (7.5%)	3
Hypertension	1/41 (2.4%)	1	1/40 (2.5%)	1
Hypoperfusion	1/41 (2.4%)	1	0/40 (0%)	0
Arrhythmia	2/41 (4.9%)	2	2/40 (5%)	2
Ear and labyrinth disorders
Thrush	1/41 (2.4%)	1	0/40 (0%)	0
Otorrhea	0/41 (0%)	0	1/40 (2.5%)	1
Endocrine disorders
Adrenal Insufficiency	4/41 (9.8%)	4	0/40 (0%)	0
Diabetes Insipidus	0/41 (0%)	0	1/40 (2.5%)	1
Hyperglycemia	9/41 (22%)	9	6/40 (15%)	6
hypoglycemia	1/41 (2.4%)	1	2/40 (5%)	2
Hyperphosphatemia	1/41 (2.4%)	1	0/40 (0%)	0
Hypocalcemia	5/41 (12.2%)	5	3/40 (7.5%)	3
Hypokalemia	5/41 (12.2%)	5	4/40 (10%)	4
Hypomagnesemia	2/41 (4.9%)	2	1/40 (2.5%)	1
Hypophosphatemia	7/41 (17.1%)	7	2/40 (5%)	2
Hypernatremia	1/41 (2.4%)	1	0/40 (0%)	0
Hyponatremia	1/41 (2.4%)	1	0/40 (0%)	0
Hyperkalemia	0/41 (0%)	0	1/40 (2.5%)	1
Gastrointestinal disorders
Acute Choleycystitis	0/41 (0%)	0	1/40 (2.5%)	1
Bowel Distention	1/41 (2.4%)	1	0/40 (0%)	0
Cholelithiasis	0/41 (0%)	0	1/40 (2.5%)	1
Constipation	6/41 (14.6%)	6	5/40 (12.5%)	5
Diarrhea	0/41 (0%)	0	1/40 (2.5%)	1
Elevated gastric residuals	1/41 (2.4%)	1	2/40 (5%)	2
vomiting	0/41 (0%)	0	1/40 (2.5%)	1
Epigastric Pain	1/41 (2.4%)	1	0/40 (0%)	0
Ileus	1/41 (2.4%)	1	0/40 (0%)	0
incontinence stool	0/41 (0%)	0	1/40 (2.5%)	1
Nausea	2/41 (4.9%)	2	3/40 (7.5%)	3
Reflux	1/41 (2.4%)	1	0/40 (0%)	0
General disorders
Multiorgan failure	6/41 (14.6%)	6	3/40 (7.5%)	3
Rhabdomyolosis	1/41 (2.4%)	1	0/40 (0%)	0
Myoglobinuria	0/41 (0%)	0	1/40 (2.5%)	1
Allergic reaction to enalapril	1/41 (2.4%)	1	0/40 (0%)	0
Hiccups	1/41 (2.4%)	1	0/40 (0%)	0
Hyperthermia	2/41 (4.9%)	2	1/40 (2.5%)	1
Pain	1/41 (2.4%)	1	2/40 (5%)	2
Hepatobiliary disorders
Elevated Liver Function Tests	1/41 (2.4%)	1	0/40 (0%)	0
Infections and infestations
Abdominal Infection	1/41 (2.4%)	1	0/40 (0%)	0
Bacteremia	2/41 (4.9%)	2	3/40 (7.5%)	3
Elevated Temperature	2/41 (4.9%)	2	2/40 (5%)	2
Postitive blood cultures	1/41 (2.4%)	1	0/40 (0%)	0
Wound Infection	3/41 (7.3%)	3	2/40 (5%)	2
Metabolism and nutrition disorders
Dysphagia	1/41 (2.4%)	1	2/40 (5%)	2
Acidosis	0/41 (0%)	0	2/40 (5%)	2
anorexia	0/41 (0%)	0	1/40 (2.5%)	1
Elevated Lactic Acid	1/41 (2.4%)	1	0/40 (0%)	0
Hyperchloremia	1/41 (2.4%)	1	0/40 (0%)	0
Nervous system disorders
Agitation	1/41 (2.4%)	1	1/40 (2.5%)	1
Delirium Tremors	1/41 (2.4%)	1	1/40 (2.5%)	1
Hyper-reflexia	0/41 (0%)	0	1/40 (2.5%)	1
insomia	5/41 (12.2%)	5	1/40 (2.5%)	1
anxiousness	1/41 (2.4%)	1	0/40 (0%)	0
Renal and urinary disorders
oliguria	2/41 (4.9%)	2	0/40 (0%)	0
Incontinence Urine	1/41 (2.4%)	1	0/40 (0%)	0
Urinary Tract Infection	4/41 (9.8%)	4	1/40 (2.5%)	1
Azotemia	1/41 (2.4%)	1	0/40 (0%)	0
acute kidney injury	1/41 (2.4%)	1	0/40 (0%)	0
Impaired Renal Function	0/41 (0%)	0	1/40 (2.5%)	1
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure	2/41 (4.9%)	2	1/40 (2.5%)	1
Pleural Effusions	5/41 (12.2%)	5	1/40 (2.5%)	1
Exacerbation COPD	1/41 (2.4%)	1	0/40 (0%)	0
Hemothorax	1/41 (2.4%)	1	2/40 (5%)	2
desaturation	1/41 (2.4%)	1	2/40 (5%)	2
Laryngeal Edema	0/41 (0%)	0	1/40 (2.5%)	1
Pneumonia	2/41 (4.9%)	2	1/40 (2.5%)	1
Pulmonary Edema	0/41 (0%)	0	1/40 (2.5%)	1
Pneumothorax	2/41 (4.9%)	2	0/40 (0%)	0
Skin and subcutaneous tissue disorders
Erythema	1/41 (2.4%)	1	0/40 (0%)	0
Skin Breakdown	3/41 (7.3%)	3	8/40 (20%)	8
Hives	0/41 (0%)	0	1/40 (2.5%)	1
Infiltration, skin	0/41 (0%)	0	1/40 (2.5%)	1
Itching, intermittant	1/41 (2.4%)	1	0/40 (0%)	0
Wound Dehiscence	0/41 (0%)	0	2/40 (5%)	2
Cellulitis	1/41 (2.4%)	1	0/40 (0%)	0
Vascular disorders
Cephalic Vein Thrombosis	2/41 (4.9%)	2	1/40 (2.5%)	1
Edema	0/41 (0%)	0	1/40 (2.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.