The Curative Effect and Security of Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percent Change of IAP After Treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 year ;
- •The diagnosis of acute pancreatitis according to the revised Atlanta classification.
- •IAH is defined as IAP ≥ 12 mmHg by the World Society of Abdominal;Compartment Syndrome (WSACS);
- •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;
- •The onset time of acute pancreatitis was within 2 weeks;
- •Signed the informed consent.
排除标准
- •Previous history of laparotomy;
- •Mechanical ileus or abdominal hemorrhage were considered clinically;
- •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;
- •Allergic to neostigmine;
- •Pregnant or lactating patients.
研究组 & 干预措施
Neostigmine
Intramuscular injection of neostigmine on the basis of conventional conservative treatment
干预措施: Neostigmine Methylsulfate 1 MG/ML (Drug)
Neostigmine
Intramuscular injection of neostigmine on the basis of conventional conservative treatment
干预措施: Conservative treatment (Combination Product)
Conservative treatment
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.
干预措施: Conservative treatment (Combination Product)
结局指标
主要结局
Percent Change of IAP After Treatment
时间窗: From randomization to 7 days after treatment,Measured IAP every 6 hours
Monitor the intra-abdominal pressure within 1 to 7 days after randomization, and calculate the percent change compared with that before randomization
次要结局
- The Change of Stool Volume at 1-7 Days After Randomization(From randomization to 7 days)
- New-onset Organ Failure(From randomization to discharge or death, assessed up to 3 months)
- Death of 90 Days(From randomization to 90 days after onset.)
- Timing of Enteral Nutrition(Start time of enteral nutrition after randomization, assessed up to 30 days)
- Number of Participants With Adverse Effects on the Cardiovascular System(From randomization to 7 days)
- New-onset Abdominal Compartment Syndrom(From randomization to discharge or death, assessed up to 4 weeks)
- Number of Participants With Deterioration of IAH(From randomization to 7 days)
研究者
Lingyu Luo
Physician-in-charge
The First Affiliated Hospital of Nanchang University