Acute Lower Gastrointestinal Dysfunction in Critical Care Patients: Should Colon or Non-colon Originated Lesions be Distinguished?
试验速览
- 阶段
- 1 期
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- ICU mortality, n (%)
研究概览
简要总结
This prospective study was designed to compare the difference of effects of conventional treatment, medicine intervention, endoscopic therapy, and surgery between colon originated and non-colon originated ALGID in critical patients, in order to alert doctors to differ the treatment of the two ALGID and provide basis for treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in our ICU aged 18-75 years.
- •Patients with a confirmed diagnosis of ALGID.
排除标准
- •mechanical intestinal obstruction (including tumor, stercoral obstruction etc.)
- •gastrointestinal hemorrhage within 72 hours.
- •history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) or radiation enteritis.
- •contraindications of neostigmine administration.
研究组 & 干预措施
Colon originated
A history of colon (-innervating) nerve damage, moderate or more severe edema; and without a history of colon (-innervating) nerve damage, with mild or severe edema of colonic wall on CT.
干预措施: Colon originated: Neostigmin, Colonoscopy decompression, Surgery (Other)
Non-colon originated
NCOG met one of the two following criteria:
- History of nerve damage that could affect colon movement (colon [-innervating] nerve damage), such as pelvic or retroperitoneal operation, spine injury, or cerebral lesion; and non-existing or mild edema of colonic wall on abdominal CT;
- Absence of history of colon(-innervating) nerve damage, with no obvious change in the colonic wall visible on the CT scan.
干预措施: Non-colon originated: Neostigmin, Colonoscopy decompression (Other)
结局指标
主要结局
ICU mortality, n (%)
时间窗: 1-28 day after ICU admission
28-day mortality after admission
时间窗: 1-28 day after admission
次要结局
- intra-abdominal pressure(1-28 day after admission)
- ICU stage, (day)(1-60 day after ICU admission)
- Hospitalization, (day)(1-60 day after admission)
- Abdominal compartment syndrome(1-28 day after admission)
研究者
Juanhong Shen
Director, PhD, Principal Investigator, Resident Physician
Chinese Medical Association