Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

AVERT Shock: Arginine Vasopressin During the Early Resuscitation of Traumatic Shock (AVERTShock)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01611935
Recruitment Status : Completed
First Posted : June 5, 2012
Results First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Collaborators:
National Trauma Research Institute
United States Department of Defense
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Traumatic Shock
Intervention Drug: Vasopressin
Enrollment 101
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vasopressin Normal Saline
Hide Arm/Group Description

Vasopressin will be given as an initial bolus (4 Units) followed by an infusion titrated between 0 units/min to 0.04 units per min to maintain a mean arterial blood pressure greater than or equal to 65 mmHg

Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours.

An initial bolus of normal saline will be given (10 cc) and an infusion of 0.1 ml per minute will be started and titrated down in as the mean arterial blood pressure reaches 65 mmHg or more.

Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours.

Period Title: Overall Study
Started 50 51
Completed 49 51
Not Completed 1 0
Reason Not Completed
Family Declined Participation             1             0
Arm/Group Title Vasopressin Normal Saline Total
Hide Arm/Group Description

Vasopressin will be given as an initial bolus (4 Units) followed by an infusion titrated between 0 units/min to 0.04 units per min to maintain a mean arterial blood pressure greater than or equal to 65 mmHg

Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours.

An initial bolus of normal saline will be given (10 cc) and an infusion of 0.1 ml per minute will be started and titrated down in as the mean arterial blood pressure reaches 65 mmHg or more.

Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours.

Total of all reporting groups
Overall Number of Baseline Participants 49 51 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 49 participants 51 participants 100 participants
26
(21 to 31)
27
(24 to 36)
26
(23 to 34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 51 participants 100 participants
Female
3
   6.1%
4
   7.8%
7
   7.0%
Male
46
  93.9%
47
  92.2%
93
  93.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 51 participants 100 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   2.0%
1
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
42
  85.7%
40
  78.4%
82
  82.0%
White
7
  14.3%
8
  15.7%
15
  15.0%
More than one race
0
   0.0%
2
   3.9%
2
   2.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants 51 participants 100 participants
49 51 100
1.Primary Outcome
Title Number of Blood Products Transfused
Hide Description Cumulative number of units of blood products, including packed red blood cells, plasma and platelets measured in liters
Time Frame 48 hours following the initiation of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vasopressin Normal Saline
Hide Arm/Group Description:

Vasopressin will be given as an initial bolus (4 Units) followed by an infusion titrated between 0 units/min to 0.04 units per min to maintain a mean arterial blood pressure greater than or equal to 65 mmHg

Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours.

An initial bolus of normal saline will be given (10 cc) and an infusion of 0.1 ml per minute will be started and titrated down in as the mean arterial blood pressure reaches 65 mmHg or more.

Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours.

Overall Number of Participants Analyzed 49 51
Median (Inter-Quartile Range)
Unit of Measure: Litre
1.7
(0.7 to 3.1)
3.0
(1.4 to 5.2)
2.Secondary Outcome
Title Need for Vasopressor Requirement Vasopressor Requirement
Hide Description total dose of vasopressors (epinephrine, norepinephrine, neosynephrine, etc) received by patient within 48 hours converted to norepinephrine equivalents (g) range in our study was from 0 gm to a max of 53 gm
Time Frame 48 hours following the initiation of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vasopressin Normal Saline
Hide Arm/Group Description:

Vasopressin will be given as an initial bolus (4 Units) followed by an infusion titrated between 0 units/min to 0.04 units per min to maintain a mean arterial blood pressure greater than or equal to 65 mmHg

Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours.

An initial bolus of normal saline will be given (10 cc) and an infusion of 0.1 ml per minute will be started and titrated down in as the mean arterial blood pressure reaches 65 mmHg or more.

Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours.

Overall Number of Participants Analyzed 49 51
Median (Inter-Quartile Range)
Unit of Measure: Norepinephrine equivalents (g)
0.6
(0 to 14)
1.5
(0.2 to 14)
3.Secondary Outcome
Title Total Number of Complications
Hide Description Variables will include intra-abdominal hypertension, open abdomen free days, ventilator-free days, ICU-free days, development of ARDS, development of renal failure, development of multiple organ failure, volume of crystalloid requirement within 48 hours post injury, and mortality.
Time Frame 30 days post injury
Hide Outcome Measure Data
Hide Analysis Population Description
patients who did not survive the 48 hours were not included in the analysis
Arm/Group Title Vasopressin Normal Saline
Hide Arm/Group Description:

Vasopressin will be given as an initial bolus (4 Units) followed by an infusion titrated between 0 units/min to 0.04 units per min to maintain a mean arterial blood pressure greater than or equal to 65 mmHg

Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours.

An initial bolus of normal saline will be given (10 cc) and an infusion of 0.1 ml per minute will be started and titrated down in as the mean arterial blood pressure reaches 65 mmHg or more.

Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours.

Overall Number of Participants Analyzed 44 47
Measure Type: Number
Unit of Measure: Complications
69 98
Time Frame 30 days post enrollment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vasopressin Normal Saline
Hide Arm/Group Description

Vasopressin will be given as an initial bolus (4 Units) followed by an infusion titrated between 0 units/min to 0.04 units per min to maintain a mean arterial blood pressure greater than or equal to 65 mmHg

Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours.

An initial bolus of normal saline will be given (10 cc) and an infusion of 0.1 ml per minute will be started and titrated down in as the mean arterial blood pressure reaches 65 mmHg or more.

Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours.

All-Cause Mortality
Vasopressin Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   5/49 (10.20%)      4/51 (7.84%)    
Hide Serious Adverse Events
Vasopressin Normal Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/49 (61.22%)      36/47 (76.60%)    
Renal and urinary disorders     
Acute Renal Failure   2/44 (4.55%)  2 8/47 (17.02%)  8
Respiratory, thoracic and mediastinal disorders     
ARDS   29/44 (65.91%)  29 36/47 (76.60%)  36
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vasopressin Normal Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/44 (50.00%)      28/47 (59.57%)    
Blood and lymphatic system disorders     
Deep Venous Thrombosis   5/44 (11.36%)  5 16/47 (34.04%)  16
Infections and infestations     
Urinary Tract Infection   1/44 (2.27%)  1 1/47 (2.13%)  1
Pneumonia   7/44 (15.91%)  7 7/47 (14.89%)  7
Wound Infection   4/44 (9.09%)  4 5/47 (10.64%)  5
Sepsis   2/44 (4.55%)  2 6/47 (12.77%)  6
Musculoskeletal and connective tissue disorders     
Extremity Compartment Syndrome   0/44 (0.00%)  0 3/47 (6.38%)  3
Rhabdomyolysis   1/44 (2.27%)  1 1/47 (2.13%)  1
Renal and urinary disorders     
Hyponatremia   5/44 (11.36%)  5 3/47 (6.38%)  3
Skin and subcutaneous tissue disorders     
Urticaria   1/44 (2.27%)  1 0/47 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Carrie Sims
Organization: University of Pennsylvania
Phone: 215-588-5154
EMail: carrie.sims@uphs.upenn.edu
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01611935    
Other Study ID Numbers: 811293
First Submitted: June 1, 2012
First Posted: June 5, 2012
Results First Submitted: January 28, 2019
Results First Posted: May 21, 2019
Last Update Posted: May 21, 2019