Trial Outcomes & Findings for Low Dose Vasopressin in Traumatic Shock (NCT NCT00420407)
NCT ID: NCT00420407
Last Updated: 2019-06-18
Results Overview
Survival of a traumatic injury subject to at least 30 days after admission to the emergency room.
Recruitment status
TERMINATED
Study phase
EARLY_PHASE1
Target enrollment
81 participants
Primary outcome timeframe
30 days
Results posted on
2019-06-18
Participant Flow
recruitment location - Emergency room Feb 2007- Feb 2009
clinical indication prohibiting potential use of vasopressin.
Participant milestones
| Measure |
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
|
Vasopressin
Vasopressin
vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
40
|
|
Overall Study
COMPLETED
|
37
|
34
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
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
|
Vasopressin
Vasopressin
vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
subject identified as detainee
|
1
|
0
|
|
Overall Study
subject identified as Jehovah's witness
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Low Dose Vasopressin in Traumatic Shock
Baseline characteristics by cohort
| Measure |
Normal Saline
n=41 Participants
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
n=40 Participants
Vasopressin
vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 26.1 • n=5 Participants
|
48.1 years
STANDARD_DEVIATION 19.8 • n=7 Participants
|
47.1 years
STANDARD_DEVIATION 20.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
40 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysSurvival of a traumatic injury subject to at least 30 days after admission to the emergency room.
Outcome measures
| Measure |
Normal Saline
n=37 Participants
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
n=34 Participants
vasopressin : 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.
|
11 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 12 hoursLevel of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm
Outcome measures
| Measure |
Normal Saline
n=34 Participants
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
|
|---|---|---|
|
Level of Vasopressin After Trauma.
|
25 pg/ml
Standard Deviation 37
|
—
|
Adverse Events
Normal Saline
Serious events: 19 serious events
Other events: 37 other events
Deaths: 0 deaths
Vasopressin
Serious events: 20 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Normal Saline
n=41 participants at risk
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
n=40 participants at risk
Vasopressin
vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
|
|---|---|---|
|
Vascular disorders
Heparin induced thrombocytopenia
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Skin and subcutaneous tissue disorders
Dehiscence, wound
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Sepsis, abdominal
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Systemic Inflamatory Response Syndrome (SIRS)
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Vascular disorders
Ischemic Necrosis Bilateral Lower Extremities
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Bacterial Meningitis
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Cardiopulmonary Arrest
|
9.8%
4/41 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
7.5%
3/40 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Cardiac disorders
Cardiac Dysrhythmia
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
exsanguination
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Hemorrhagic Shock
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
7.5%
3/40 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Cardiac disorders
Hypertenson
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Multisystem Trauma
|
7.3%
3/41 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Cardiac disorders
Cardiac Arrhythmia
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Vascular disorders
reperfusion syndrome
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Gastrointestinal disorders
Ogilvies Syndrome
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Gastrointestinal disorders
Upper GI bleed
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
7.5%
3/40 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Skin and subcutaneous tissue disorders
Cellutlitis
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Shock, Septic
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Multiple Organ Failure
|
4.9%
2/41 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
10.0%
4/40 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Vascular disorders
Compartment Syndrome
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Nervous system disorders
Traumatic Brain Injury (TBI)
|
7.3%
3/41 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
10.0%
4/40 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome (ARDS)
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Empyema
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
9.8%
4/41 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
7.5%
3/40 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Emboli
|
4.9%
2/41 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Retroperitoneal bleed
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Pulmonary Hemorrhage
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Renal and urinary disorders
Renal Insufficiency, worsening
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Infections and infestations
Candidemia
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
Other adverse events
| Measure |
Normal Saline
n=41 participants at risk
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
n=40 participants at risk
Vasopressin
vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
4.9%
2/41 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
7.5%
3/40 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Cardiac disorders
Hypertension
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Cardiac disorders
Hypoperfusion
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Cardiac disorders
Arrhythmia
|
4.9%
2/41 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Endocrine disorders
Adrenal Insufficiency
|
9.8%
4/41 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Endocrine disorders
Diabetes Insipidus
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Endocrine disorders
Hyperglycemia
|
22.0%
9/41 • Number of events 9 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
15.0%
6/40 • Number of events 6 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Endocrine disorders
hypoglycemia
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Endocrine disorders
Hyperphosphatemia
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Endocrine disorders
Hypocalcemia
|
12.2%
5/41 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
7.5%
3/40 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Endocrine disorders
Hypokalemia
|
12.2%
5/41 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
10.0%
4/40 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Endocrine disorders
Hypomagnesemia
|
4.9%
2/41 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Endocrine disorders
Hypophosphatemia
|
17.1%
7/41 • Number of events 7 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Metabolism and nutrition disorders
Dysphagia
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Ear and labyrinth disorders
Thrush
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Endocrine disorders
Hypernatremia
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Endocrine disorders
Hyponatremia
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Endocrine disorders
Hyperkalemia
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Ear and labyrinth disorders
Otorrhea
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Gastrointestinal disorders
Acute Choleycystitis
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Gastrointestinal disorders
Bowel Distention
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Gastrointestinal disorders
Cholelithiasis
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Gastrointestinal disorders
Constipation
|
14.6%
6/41 • Number of events 6 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
12.5%
5/40 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Gastrointestinal disorders
Elevated gastric residuals
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Gastrointestinal disorders
Epigastric Pain
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Gastrointestinal disorders
Ileus
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Gastrointestinal disorders
incontinence stool
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Gastrointestinal disorders
Nausea
|
4.9%
2/41 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
7.5%
3/40 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Renal and urinary disorders
oliguria
|
4.9%
2/41 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Renal and urinary disorders
Incontinence Urine
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Renal and urinary disorders
Urinary Tract Infection
|
9.8%
4/41 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Blood and lymphatic system disorders
Anemia
|
7.3%
3/41 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
12.5%
5/40 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Blood and lymphatic system disorders
Dilitional Thrombocytopenia
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Blood and lymphatic system disorders
Elevated INR
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Vascular disorders
Cephalic Vein Thrombosis
|
4.9%
2/41 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Hepatobiliary disorders
Elevated Liver Function Tests
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Infections and infestations
Abdominal Infection
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Infections and infestations
Bacteremia
|
4.9%
2/41 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
7.5%
3/40 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Infections and infestations
Elevated Temperature
|
4.9%
2/41 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Infections and infestations
Postitive blood cultures
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Infections and infestations
Wound Infection
|
7.3%
3/41 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Skin and subcutaneous tissue disorders
Skin Breakdown
|
7.3%
3/41 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
20.0%
8/40 • Number of events 8 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Skin and subcutaneous tissue disorders
Hives
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Skin and subcutaneous tissue disorders
Infiltration, skin
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Skin and subcutaneous tissue disorders
Itching, intermittant
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Skin and subcutaneous tissue disorders
Wound Dehiscence
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Multiorgan failure
|
14.6%
6/41 • Number of events 6 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
7.5%
3/40 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Rhabdomyolosis
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Myoglobinuria
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Vascular disorders
Edema
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Nervous system disorders
Agitation
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Allergic reaction to enalapril
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Metabolism and nutrition disorders
anorexia
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Nervous system disorders
Delirium Tremors
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Renal and urinary disorders
Azotemia
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Metabolism and nutrition disorders
Elevated Lactic Acid
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Hiccups
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Nervous system disorders
Hyper-reflexia
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Hyperthermia
|
4.9%
2/41 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Nervous system disorders
insomia
|
12.2%
5/41 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Nervous system disorders
anxiousness
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Metabolism and nutrition disorders
Hyperchloremia
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
General disorders
Pain
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Gastrointestinal disorders
Reflux
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Renal and urinary disorders
acute kidney injury
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Renal and urinary disorders
Impaired Renal Function
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
4.9%
2/41 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusions
|
12.2%
5/41 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation COPD
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Respiratory, thoracic and mediastinal disorders
desaturation
|
2.4%
1/41 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
5.0%
2/40 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Edema
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.9%
2/41 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/41 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
2.5%
1/40 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.9%
2/41 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
0.00%
0/40 • Reported Adverse Events (AEs) include events starting on or after Day 0 or before Day 30
|
Additional Information
Stephen Cohn, M.D.
University of Texas Health Science Center at San Antonio
Phone: 210-567-5724
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place