Table 4. Adverse Events by Treatment Group.
Adverse Event | Study Group | |
---|---|---|
AVP Supplementation (n = 44) | Placebo (n = 47) | |
Any adverse event, No. (%) of patientsa | 35 (80) | 39 (83) |
No. of adverse events | 69 | 98 |
Adverse event, No. (%) of patients | ||
Deep venous thrombosis | 5 (11) | 16 (34) |
Pulmonary embolus | 2 (5) | 3 (6) |
Urinary tract infection | 1 (2) | 1 (2) |
Ventilator-associated pneumonia | 7 (16) | 7 (15) |
Acute renal failure | 2 (5) | 8 (17) |
Acute respiratory distress syndrome | 29 (66) | 36 (77) |
Gastrointestinal bleeding | 2 (5) | 1 (2) |
Major dysrhythmia | 0 | 1 (2) |
Wound infection | 4 (9) | 5 (11) |
Sepsis | 2 (5) | 6 (13) |
Extremity compartment syndrome | 0 | 3 (6) |
Coagulopathy | 2 (5) | 3 (6) |
Soft tissue infection | 4 (9) | 2 (4) |
Ischemia | 1 (2) | 2 (4) |
Hyponatremia | 5 (11) | 3 (6) |
Urticaria | 1 (2) | 0 |
Arterial thrombosis | 1 (2) | 0 |
Rhabdomyolysis | 1 (2) | 1 (2) |
Abbreviation: AVP, arginine vasopressin.
P = .67 based on χ2 test.