Trial Outcomes & Findings for AVERT Shock: Arginine Vasopressin During the Early Resuscitation of Traumatic Shock (NCT NCT01611935)
NCT ID: NCT01611935
Last Updated: 2019-05-21
Results Overview
Cumulative number of units of blood products, including packed red blood cells, plasma and platelets measured in liters
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
48 hours following the initiation of therapy
Results posted on
2019-05-21
Participant Flow
Participant milestones
| Measure |
Vasopressin
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.
|
Normal Saline
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 Study
STARTED
|
50
|
51
|
|
Overall Study
COMPLETED
|
49
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Vasopressin
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.
|
Normal Saline
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 Study
Family Declined Participation
|
1
|
0
|
Baseline Characteristics
AVERT Shock: Arginine Vasopressin During the Early Resuscitation of Traumatic Shock
Baseline characteristics by cohort
| Measure |
Vasopressin
n=49 Participants
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.
|
Normal Saline
n=51 Participants
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
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
n=5 Participants
|
27 years
n=7 Participants
|
26 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
51 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hours following the initiation of therapyCumulative number of units of blood products, including packed red blood cells, plasma and platelets measured in liters
Outcome measures
| Measure |
Vasopressin
n=49 Participants
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.
|
Normal Saline
n=51 Participants
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.
|
|---|---|---|
|
Number of Blood Products Transfused
|
1.7 Litre
Interval 0.7 to 3.1
|
3.0 Litre
Interval 1.4 to 5.2
|
SECONDARY outcome
Timeframe: 48 hours following the initiation of therapytotal 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
Outcome measures
| Measure |
Vasopressin
n=49 Participants
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.
|
Normal Saline
n=51 Participants
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.
|
|---|---|---|
|
Need for Vasopressor Requirement Vasopressor Requirement
|
0.6 Norepinephrine equivalents (g)
Interval 0.0 to 14.0
|
1.5 Norepinephrine equivalents (g)
Interval 0.2 to 14.0
|
SECONDARY outcome
Timeframe: 30 days post injuryPopulation: patients who did not survive the 48 hours were not included in the analysis
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.
Outcome measures
| Measure |
Vasopressin
n=44 Participants
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.
|
Normal Saline
n=47 Participants
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 Number of Complications
|
69 Complications
|
98 Complications
|
Adverse Events
Vasopressin
Serious events: 30 serious events
Other events: 22 other events
Deaths: 5 deaths
Normal Saline
Serious events: 36 serious events
Other events: 28 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Vasopressin
n=44 participants at risk；n=49 participants at risk
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.
|
Normal Saline
n=47 participants at risk
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.
|
|---|---|---|
|
Renal and urinary disorders
Acute Renal Failure
|
4.5%
2/44 • Number of events 2 • 30 days post enrollment
|
17.0%
8/47 • Number of events 8 • 30 days post enrollment
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
65.9%
29/44 • Number of events 29 • 30 days post enrollment
|
76.6%
36/47 • Number of events 36 • 30 days post enrollment
|
Other adverse events
| Measure |
Vasopressin
n=44 participants at risk；n=49 participants at risk
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.
|
Normal Saline
n=47 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Deep Venous Thrombosis
|
11.4%
5/44 • Number of events 5 • 30 days post enrollment
|
34.0%
16/47 • Number of events 16 • 30 days post enrollment
|
|
Infections and infestations
Urinary Tract Infection
|
2.3%
1/44 • Number of events 1 • 30 days post enrollment
|
2.1%
1/47 • Number of events 1 • 30 days post enrollment
|
|
Infections and infestations
Pneumonia
|
15.9%
7/44 • Number of events 7 • 30 days post enrollment
|
14.9%
7/47 • Number of events 7 • 30 days post enrollment
|
|
Infections and infestations
Wound Infection
|
9.1%
4/44 • Number of events 4 • 30 days post enrollment
|
10.6%
5/47 • Number of events 5 • 30 days post enrollment
|
|
Infections and infestations
Sepsis
|
4.5%
2/44 • Number of events 2 • 30 days post enrollment
|
12.8%
6/47 • Number of events 6 • 30 days post enrollment
|
|
Musculoskeletal and connective tissue disorders
Extremity Compartment Syndrome
|
0.00%
0/44 • 30 days post enrollment
|
6.4%
3/47 • Number of events 3 • 30 days post enrollment
|
|
Renal and urinary disorders
Hyponatremia
|
11.4%
5/44 • Number of events 5 • 30 days post enrollment
|
6.4%
3/47 • Number of events 3 • 30 days post enrollment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.3%
1/44 • Number of events 1 • 30 days post enrollment
|
0.00%
0/47 • 30 days post enrollment
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
2.3%
1/44 • Number of events 1 • 30 days post enrollment
|
2.1%
1/47 • Number of events 1 • 30 days post enrollment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place