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临床试验/NCT01507766
NCT01507766已完成4 期

The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis

Nanjing University School of Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Enteral nutrition

研究概览

简要总结

As an important management of severe acute pancreatitis (SAP), enteral nutrition (EN), especially early enteral nutrition (EEN) increases the blood flow of gut mucosa and stimulates the intestinal motility. Moreover, EEN maintains the gut integrity, prevents bacterial and endotoxin translocation and thereby theoretically reduces the incidence of infections. Therefore, EEN has the ability to reduce the infectious complications, length of hospital stay and mortality of patients with SAP.

However, the role of EEN is considered to be influenced by intra-abdominal hypertension (IAH) in patients with SAP. The previous studies showed that gut was the most sensitive splanchnic organ to the increase of intra-abdominal pressure (IAP). When IAH occurs, it reduces the blood flow of gut, and then results in the development of intestinal ischemia and edema. The hypoxia and hypoperfusion of intestine leads to the increase of permeability of the intestinal mucosal barrier, and then leads to bacterial translocation. Therefore, IAH could result in the gastrointestinal dysfunction. Nevertheless, the different impacts of specific IAP values on the tolerance of EEN have not been reported.

Furthermore, the effects of early enteral feeding on the IAP in SAP also remain unknown. Due to the severe inflammatory response of SAP, could EEN increase the burden of bowel, cause expansion of intestinal cavity, thus increase IAP? However, there were rare literatures up to date reporting the association between EEN and IAH in patients with SAP. Therefore, the present study aimed to investigate the influence of specific IAP on the tolerance of early enteral feeding, as well as the effects of EEN on IAP in SAP patients. Moreover, the impacts of EEN on the disease severity and clinical outcome of SAP were also researched.

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

入选标准

  • The diagnosis of acute pancreatitis accords with the Atlanta criteria in 1992
  • Within 3 days from the onset of the disease
  • Hemodynamics stable

排除标准

  • Decompressive measures and enteral nutrition was performed before admission
  • Ileus of lower digestive tract
  • Pregnant pancreatitis
  • Chronic organs dysfunction
  • Immunodeficiency

研究组 & 干预措施

Early enteral nutrition

Experimental

The enteral nutrition was started within 48h after admission

干预措施: early enteral nutrition (Drug)

Delayed enteral nutrition

Active Comparator

The enteral nutrition was started at the 8th day after admission

干预措施: Delayed enteral nutrition (Drug)

结局指标

主要结局

Enteral nutrition

时间窗: 14 days

The caloric intake and tolerance of feeding were recorded daily after enteral nutrition was started

Intra-abdominal pressure

时间窗: 14 days

The value of intra-abdominal pressure (per 6 hours) and the incidence of intra-abdominal hypertension

次要结局

  • Clinical outcome variables(14 days)
  • Immune parameters(14 days)

研究者

发起方
Nanjing University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiakui Sun

Principal Investigator

Nanjing University School of Medicine

研究点 (1)

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