Clinical trial NCT02543658: Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension
Official title: The Curative Effect and Security of Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pancreatitis
Intra-abdominal Hypertension
Keywords: Acute Pancreatitis
Intra-abdominal hypertension
Abdominal compartment syndrome
Curative Effect
Security
Neostigmine
Lead sponsor: The First Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-70 year ;
2. The diagnosis of acute pancreatitis according to the revised Atlanta classification.
3. IAH is defined as IAP ≥ 12 mmHg by the World Society of Abdominal;Compartment Syndrome (WSACS);
4. After 24 hours of conventional treatment(such as gastrointestinal decompression or percutaneous drainage of ascites), the IAP of AP patients with IAH was still ≥ 12 mmHg;
5. The onset time of acute pancreatitis was within 2 weeks;
6. Signed the informed consent.

Exclusion Criteria:

1. Previous history of laparotomy;
2. Mechanical ileus or abdominal hemorrhage were considered clinically;
3. Those who have contraindications to neostigmine: 1) Patients with angina; 2) myocardial infarction; 3) ventricular tachycardia; 4) bradycardia; 5) acute circulatory failure; 6) epilepsy; 7) bronchial asthma; 8) mechanical intestinal obstruction; 9) urinary tract infarction; 10) hyperthyroidism; 11) serious arrhythmia; 12) bladder operation; 13) intestinal fistula;
4. Allergic to neostigmine;
5. Pregnant or lactating patients.

Primary outcomes:
measure: Percent Change of IAP After Treatment
timeFrame: From randomization to 7 days after treatment,Measured IAP every 6 hours
Secondary outcomes:
measure: The Change of Stool Volume at 1-7 Days After Randomization
timeFrame: From randomization to 7 days
measure: New-onset Abdominal Compartment Syndrom
timeFrame: From randomization to discharge or death, assessed up to 4 weeks
measure: New-onset Organ Failure
timeFrame: From randomization to discharge or death, assessed up to 3 months
measure: Death of 90 Days
timeFrame: From randomization to 90 days after onset.
measure: Timing of Enteral Nutrition
timeFrame: Start time of enteral nutrition after randomization, assessed up to 30 days
measure: Number of Participants With Deterioration of IAH
timeFrame: From randomization to 7 days
measure: Number of Participants With Adverse Effects on the Cardiovascular System
timeFrame: From randomization to 7 days
Other outcomes:
measure: Days in Hospital
timeFrame: From randomisation to 6 months
measure: Days in ICU
timeFrame: From randomisation to 6 months
measure: Medical Expenses
timeFrame: From randomisation to 6 months
Locations:
city: Nanchang
country: China
facility: Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
affiliation: the Frist Affiliated Hospital of Nanchang University
name: Nonghua Lv, MD
role: STUDY_CHAIR
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