Randomized controlled trial: neostigmine for intra-abdominal hypertension in acute pancreatitis

Table 2 Intention-to-treat analysis of baseline characteristics

Characteristic	Neostigmine (n = 40)	Conventional (n = 40)	P value
Age (year)	46 ± 13	49 ± 14	0.85
Sex (m/f)	27/13	34/6	0.11
Etiology
Biliary	12 (30.0%)	14 (35.0%)	0.95
Hypertriglyceridemia^a	21 (52.5%)	20 (50.0%)
Alcohol excess	4 (10.0%)	4 (10.0%)
Idiopathic	3 (7.5%)	2 (5.0%)
AP onset to hospital admission (d)	3 (1–4)	2 (1–3)	0.06
AP onset to randomization (d)	5 (3–7)	5 (4–6)	0.55
Comorbidity
Diabetes mellitus	3 (7.5%)	6 (15.0%)	0.48
Hypertension	2 (5.0%)	7 (17.5%)	0.15
Coronary heart disease	1 (2.5%)	0	1.00
Chronic renal insufficiency	0	1 (2.5%)	1.00
Admission clinical severity
SIRS	2 (2–3)	2 (2–3)	0.70
APACHE II	9 (7–9)	9 (7–12)	0.79
C-reactive protein (mg/L)	228.6 ± 144.1	295.8 ± 125.8	0.70
White cell count (× 10⁹/L)	14.7 ± 5.9	14.2 ± 5.6	0.45
Procalcitonin (ng/mL)	1.7 (0.6–13.7)	2.8 (1.3–6.7)	0.40
Serum lactate	2.0 ± 1.3	1.7 ± 0.9	0.16
Organ failure^b	32 (80.0%)	27 (67.5%)	0.31
Single organ failure
Respiratory	21 (52.5%)	17 (42.5%)	0.50
Renal	3 (7.5%)	1 (2.5%)	0.61
Multiple organ failure	8 (20.9%)	9 (22.5%)	1.00
CTSI within 1 week of AP onset^c	5 (3–7)	5 (3–7)	0.99
ANC	28 (73.7%)	26 (76.4%)	0.63
APFC	10 (26.3%)	8 (23.5%)	0.59
IAH level before randomization, mmHg	16.3 ± 2.7	15.9 ± 2.4	0.63
Grade I	15 (37.5%)	17 (42.5%)
Grade II	22 (55.0%)	21 (52.5%)
Grade III	3 (7.5%)	2 (5.0%)
Grade IV	0	0
ACS	9 (22.5%)	6 (15.0%)	0.56
Use of opioids	4 (10.0%)	1 (2.5%)	0.36
Colonic ileus^c,d	3 (7.9%)	0	0.11
24 h of defecation (mL)	450 (10–1050)	800 (520–990)	0.14
PCD of ascites	10 (25.0%)	6 (15.0%)	0.40
Admitted to the ICU at randomization	40 (100%)	40 (100%)	1.00

ACS abdominal compartment syndrome, AP acute pancreatitis, APACHE II acute physiology and chronic health evaluation II, APFC acute peripancreatic fluid collection, ANC acute necrotic collection, CTSI computed tomography severity index, IAH intra-abdominal hypertension, ICU Intensive Care Unit, PCD percutaneous catheter drainage, RAC Revised Atlanta Classification, SAP severe acute pancreatitis, SIRS systemic inflammatory response syndrome
^aDefined as admission serum triglyceride level > 1000 mg/dL and/or lipemic serum after ruling out biliary and alcohol excess etiologies
^bPatients with circulatory failure were excluded because neostigmine may affect the circulation
^cThere were 38 and 34 cases in the neostigmine group and conventional group, respectively, underwent CT within the first week after AP onset
^dOpioids were used in 2 of the 3 patients with colonic ileus

ISSN: 1364-8535