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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
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.
Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Percent Change of IAP After Treatment
Monitor the intra-abdominal pressure within 1 to 7 days after randomization, and calculate the percent change compared with that before randomization
Time frame: From randomization to 7 days after treatment,Measured IAP every 6 hours
The Change of Stool Volume at 1-7 Days After Randomization
After randomization, the change of stool volume (ML) was calculated every 24 hours.For example, the amount of stool volume decreased or increased in 24 hours after grouping compared to before grouping.
Time frame: From randomization to 7 days
New-onset Abdominal Compartment Syndrom
Abdominal compartment syndrome is defined as a sustained IAP\>20 mmHg (with or without an APP\<60 mmHg) that is associated with new organ dysfunction/failure
Time frame: From randomization to discharge or death, assessed up to 4 weeks
New-onset Organ Failure
Incidence of organ failure from randomization to discharge or death, assessed up to 3 months
Time frame: From randomization to discharge or death, assessed up to 3 months
Death of 90 Days
Death during from randomization to 90 days after onset.
Time frame: From randomization to 90 days after onset.
Timing of Enteral Nutrition
From date of randomization to enteral nutrition, assessed up to 30 days
Time frame: Start time of enteral nutrition after randomization, assessed up to 30 days
Number of Participants With Deterioration of IAH
IAP rebound ≥ 5mmHg or increase ≥ 20mmHg within 1-7 days after grouping
Time frame: From randomization to 7 days
Number of Participants With Adverse Effects on the Cardiovascular System
Due to that neostigmine has an inhibitory effect on the cardiovascular system, new-onset cardiovascular failure after grouping is considered as a possible adverse event related to neostigmine.Cardiovascular failure was defined as circulatory systolic blood pressure \<90 mm Hg, despite adequate fluid resuscitation, or need for inotropic catecholamine support
Time frame: From randomization to 7 days
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