COLITIS: Clostridial Infection and Oral Lavage -Improving Treatment Before Illness Becomes Severe
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Length of stay
研究概览
简要总结
Once the lab test is positive for c. diff, the investigators will order the patient to have PEG 3350 solution, one 8oz glass every ten minutes until 6 liters are gone, but if still not clear 2 more liters may be ordered. At enrollment, the treatment arm will have an order for 500 cc Normal saline to be given I.V. The patient will continue with antibiotic treatment as well. The investigators will plan to check c. diff tests daily to see when they become negative. The investigators will perform chart audit/review to track mortality, the length of stay, ICU days, surgical intervention, and APACHE scores (assessment of disease severity). Chart audit will be used to collect data on their diet and how they feel using a visual analog scale (collected by nursing staff daily as a standard procedure; see attached pain scale). Using chart audit, the investigators will record whether the patient is immunocompromised or not.
详细描述
Project Summary:
Clostridium Difficile (c. diff) is a bacteria which causes much morbidity and mortality worldwide. It does so by causing diarrhea and abdominal pain. It can be mild and self-limited, to severe and lethal, even in developed countries. It can require removal of the colon to try to spare a victim's life. This isn't always successful. Current treatment is withdrawal of any unnecessary antibiotics, addition of one of two antibiotics that work pretty reliably against c.diff, hydration, and observation for signs the patient might need to be operated.
The investigators propose that instead of trying to kill the bacteria that are a problem, with limited antibiotic choices, the investigators can give the patient a bowel prep and quickly and reliably wash the bacteria, and the toxin that actually wreaks the havoc, out of their system.
The investigators will collect variables of mortality, LOS, ICU days, surgical interventions (colectomy or ileostomy and lavage), time to test negative after treatment starts, and APACHE scores. The investigators will track when regular diet is resumed. The investigators will track immunocompromised state and see the effect it has. The investigators will use a visual analog scale to assess time to feel better as well.
Project description:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older male or female testing positive for c. diff
排除标准
- •Pregnancy Less than 18 yrs of age Those sick enough to require surgery at diagnosis Severe ileus or small bowel obstruction
研究组 & 干预措施
Nu-Lytely
Bowel prep solution.
干预措施: Nu-Lytely (Drug)
结局指标
主要结局
Length of stay
时间窗: 30 days
Days
次要结局
- Need for surgery(30 days)
研究者
Mark Vance
DO, Attending Surgeon
Ascension Health