Acute pancreatitis
Conditions
Interventions
Neostigmine group:Neostigmine methsulfate injection: Usage: 1mg / 1 dose, intramuscular injection every 12h for 7 days.
Control group:Placebo (saline) control. Dosage: 2ml/1 vial, intramuscular injection in the buttock, every 12h for 7 days
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~70 years old, gender is not limited; 2. The course of the disease=; or BISAP > = 3 points; OR APACHE II> = 8 POINTS 4. IAP>15 mmHg and <=25mmHg (indirect measurement of the bladder);
Exclusion criteria
Exclusion criteria: 1. Patients with AP who have relapsed within 3 months; 2. Have a history of laparotomy; 3. Mechanical intestinal obstruction, or active bowel sounds (> = 6 beats per minute) 4. Abdominal compartment syndrome (ACS) has occurred: 3 consecutive IAPs >=20mmHg in 24 hours, with or without peritoneal perfusion pressure 3 6. Severe arrhythmia: ventricular tachycardia, ventricular fibrillation, tachyatrial fibrillation, atrial flutter, bradycardia< 50 beats/min 7. Intra-abdominal hemorrhage or cyst rupture; 8. Intestinal fistula or severe intestinal ischemia with one of the following signs: abdominal muscles are highly tense and plate-like abdomen; Hematemesis or blood in the stool; 9. There are other contraindications to the use of neostigmine: angina, myocardial infarction, epilepsy, bronchial asthma, urinary tract obstruction, hyperthyroidism, or allergy to neostigmine; 10. Pregnancy or lactation; 11. Refusal to sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite endpoint of mortality from major complications (new-onset organ failure, enteric fistula, and intra-abdominal bleeding) within 30 days after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduce the IAP effect;Daily bowel volume 24 hours to 7 days after randomization;Arterial lactate;New ACS;New-onset respiratory failure;Intensive care time;Total length of hospital stay;Hospitality;Duration of respiratory failure;Number of days without respiratory failure within 30 days;New-onset renal failure;Number of days without renal failure within 30 days;New-onset circulatory failure;Acute gastrointestinal injury (AGI) score;Intra-abdominal bleeding;Gastrointestinal fistula:;Sepsis ;Incidence of infectious pancreatic necrosis;Portal vein thrombosis;Start time of enteral nutrition;Case fatality rate ;Follow-up for 6 months;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactZhu Yin
The First Affiliated Hospital of Nanchang University
Outcome results
None listed