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. 2022 Mar 3;26:52. doi: 10.1186/s13054-022-03922-4

Table 1.

Definition of the primary and secondary endpoints

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