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临床试验/NCT01919060
NCT01919060已完成不适用

Acute Non-mechanical Lower Digestive Tract Disorders Should Distinguish Whether Colonic Lesions or Not in Critically Ill Patients

Nanjing PLA General Hospital0 个研究点目标入组 69 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
69
主要终点
All cause mortality

研究概览

简要总结

The purpose of the study is to investigate acute non-mechanical lower digestive tract disorders should distinguish whether colonic lesions or not in critically ill patients

详细描述

The study was approved by the ethics committee of Jinling hospital and the medical school of nanjing university. This prospective study was performed at a surgical intensive care unit (SICU), which contain 39 beds, of general surgical departement of Jinling hospital, affiliated hospital of medical school of nanjing university. Written informed consents were obtained from the patients or their next of kin.

Critical patients aging from 18 to 80 years old diagnosed with acute lower gastrointestinal dysfunction were recrutied to the study. The two following criterias should met for the diagnosis of acute lower gastrointestinal dysfunction: 1. enteral nutrition intolerance not due to upper gastriointestinal obstruction; 2. Colonic distension: colonic diameter >6 cm or ileocecus diameter >9 cm under the view of computed tomography or abdomial X ray. Enteral nutrition intolerance was defined as enteral feeding < 50% caculated needs or no feeding for three days.

Patients with following conditions were excluded: mechanical intestinal obstruction (including tomor, stercoral obstruction etc); gastrointestinal hemorrhage within 72 hours; history of inflammatory bowel disease (ulcerative colitis or crohn's disease) or radiation enteritis; pregnancy; having the contradiction of proserine administration.

Data on demagraphy, diagnosis, treatment as well as APACHE Ⅱ and SOFA score within 24 hs of admission were recorded. The included patients were examined by contrast-enhanced abdominal CT, and were devided into two groups, colon oriented group and non-colon oriented group, independently by 2 professionals combining the history and CT results. Non-colon oriented group should met one of the two following crieria: 1. with a history of nerves damage which affect colon movement (colon(-innervating) nerves damage) (such as pevic or retroperitoneal operation, spine injury, cerebral lesion), and non- or mild edema of colonic wall presented on abdominal CT; 2. without a history of colon(-innervating) nerves damage, whereas no obvious change can be seen on CT scan. The others were clarified as colon-oriented group (namely, with a history of colon(-innervating) nerves damage, moderate or more severe edema; without a history of colon(-innervating) nerves damage, whereas mild or sever edema presented ).

All the patients diagnosed with acute lower gastrointestinal dysfunction were treated according to the protocol depicted in figure 1.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Critical patients aging from 18 to 80 years old diagnosed with acute lower gastrointestinal dysfunction
  • enteral nutrition intolerance not due to upper gastriointestinal obstruction
  • Colonic distension: colonic diameter >6 cm or ileocecus diameter >9 cm under the view of computed tomography or abdomial X ray. Enteral nutrition intolerance was defined as enteral feeding < 50% caculated needs or no feeding for three days -

排除标准

  • mechanical intestinal obstruction (including tomor, stercoral obstruction etc); gastrointestinal hemorrhage within 72 hours; history of inflammatory bowel disease (ulcerative colitis or crohn's disease) or radiation enteritis; pregnancy; having the contradiction of proserine administration. -

结局指标

主要结局

All cause mortality

时间窗: 28

次要结局

  • Organ failure or dysfunction(28day)

研究者

发起方
Nanjing PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gao Tao

Nanjing university

Nanjing PLA General Hospital

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