Table 1.
Endpoint | Definition |
---|---|
IAH | A sustained or repeated pathological elevation in IAP ≥ 12 mmHg |
IAH grade | Grade I, IAP 12–15 mmHg |
Grade II, IAP 16–20 mmHg | |
Grade III, IAP 21–25 mmHg | |
Grade IV, IAP > 25 mmHg | |
ACS | A sustained IAP > 20 mmHg (with or without an APP < 60 mmHg) that is associated with new organ dysfunction/failure |
Increase in stool volume | Increase in 24 h stool volume on a designated day (day 1, day 2, day 3, day 5, and day 7) after randomization above the baseline 24 h stool volume before randomization |
New-onset ACS | ACS occurring after randomization (not present at any time before it), assessed for up to 4 weeks |
Deterioration of IAH | IAP that rebounds ≥ 5 mmHg or increases to ≥ 20 mmHg within 7 days after randomization |
New-onset organ failure | Organ failure occurring after randomization (not present at any time before randomization) |
Multiple-organ failure | Failure of two or more organs |
Respiratory failure | PaO2/FiO2 ≤ 300, or requirement for mechanical ventilation |
Circulatory failure | Circulatory systolic blood pressure < 90 mmHg, despite adequate fluid resuscitation, or requirement for inotropic catecholamine support |
Renal failure | Creatinine level > 177 μmol/L after rehydration or new need for haemofiltration or hemodialysis |
Timing of EN | Time from randomization to the initiation of tolerated EN |
Intra-abdominal bleeding | Intra-abdominal bleeding that requires surgical, radiologic, or endoscopic intervention |
Enterocutaneous or enteric fistula | Secretion of fecal material from a percutaneous drain or inflow into a necrotic cavity, either from small or large bowel, confirmed by endoscopy, imaging, or during surgery |
Adverse event | The following events occurred during the use of neostigmine: drug eruption, ataxia, convulsions, coma, slurred speech, anxiety, fear, cardiac arrest, or other untoward events not characteristic of or expected from AP; diarrhea was excluded as this was part of the therapeutic effect to reduce IAP |
ACS abdominal compartment syndrome, APP intraperitoneal perfusion pressure, EN enteral nutrition, IAH intra-abdominal hypertension, IAP intra-abdominal pressure