Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension
Condition: Acute Pancreatitis; Intra-abdominal Hypertension
MeSH terms: Intra-Abdominal Hypertension; Pancreatitis; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Acute pancreatitis(A) often complicated with Intra-abdominal Hypertension. After the onset of
      acute pancreatitis, capillary leakage causing ascites,upper gastrointestinal tract
      obstruction and paralytic ileus leading to an elevated IAP, severe IAH leads to ACS with high
      mortality. Neostigmine is an anti-cholinesterase drugs, can enhance intestinal peristalsis,
      promote flatus defecation. The aim of this study was to determine the effect of neostigmine
      on reducing abdominal pressure and clinical prognosis in patients with AP by promoting
      intestinal peristalsis and defecation.
    

Detailed description: 
      Acute pancreatitis(AP) runs a severe course in around 20% of patients and is associated with
      a mortality up to 30%. Intra-abdominal hypertension(IAH）is a common complication of severe
      acute pancreatitis(SAP). The inflammation of the pancreas starts a cascade of pancreatic and
      visceral edema, acute peripancreatic fluid collections, capillary leakage causing ascites,
      paralytic ileus, and gastric dilatation by upper gastrointestinal tract obstruction leading
      to an elevated intra-abdominal pressure (IAP). A sustained or repeated pathological elevation
      in IAP ≥12 mmHg is defined as IAH, it generally occurs often within the first week after
      onset of SAP. Persistent and serious IAH (IAP >20 mmHg ) often leads to new onset organ
      failure or acute worsening of existing organ failure, which is defined as ACS and associated
      with a mortality rate of 49%.

      In the past practice, many patients with ACS undergo decompressive laparotomy, which
      obviously has a risk of complications. Therefore, numerous medical, nonmedical, and minimally
      invasive therapies have been introduced. Neostigmine is an anti-cholinesterase drugs, can
      enhance intestinal peristalsis, promote flatus defecation. World Society for Abdominal
      Compartment Syndrome (WSACS)guidelines,suggest that neostigmine be used for the treatment of
      established colonic ileus not responding to other simple measures and associated with
      IAH.However, no data exist on the effects of pharmacologic promotility therapy on IAP or
      outcomes among those with IAH/ACS. The aim of this study was to evaluate the efficacy of
      neostigmine on reducing IAP in AP patients with IAH.
    

Intervention name(s): Neostigmine Methylsulfate 1 MG/ML; Conservative treatment
Intervention type(s): Drug; Combination Product
Intervention description(s): The initial dose was 1mg, intramuscular injection(IM) once every 12 hours. If there is no defecation after 12 hours, the dose is increased to 1mg IM once every 8 hours; if there is no defecation after 24 hours, the dose is increased to 1mg IM once every 6 hours. If the abdominal pressure drops below 12mmhg, neostigmine will be stopped, otherwise it will be used continuously for 7 days.; Intragastric administration of paraffin oil, 50ml,once every 8 hours；gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
Other intervention name(s): Prostigmin; Non-surgical treatment
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acute Pancreatitis; Intra-abdominal hypertension; Abdominal compartment syndrome; Curative Effect; Security; Neostigmine