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临床试验/NCT06240585
NCT06240585已完成不适用

Gastroparesis as an Early Sign of Sepsis

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
260
试验地点
1
主要终点
gastroparesis as an early sign for sepsis (bacteremia)

研究概览

简要总结

Upper gastrointestinal tract disorders, such as gastroparesis, are common in critically ill patients in the ICU, estimated at 60%. Gastroparesis symptoms include nausea, vomiting and abdominal pain. Risk factors for the development of gastroparesis include diabetes, surgical injury to the vagus nerve (such as certain types of bariatric surgery, and in the past - surgeries for patients who suffered from peptic ulcer), use of drugs that inhibit the activity of the digestive system such as opiates, anticholinergic drugs, sepsis, as well as being bedridden and inactive - are all common conditions in critically ill patients.

There are different definitions for gastroparesis. One of the accepted definitions refers to gastric residual volume (GRV) over 200 ml at one measurement. Gastroparesis is found in some studies to be associated with increased morbidity and mortality in critically ill patients. As mentioned above, it is known that sepsis is a risk factor for gastroparesis. According to our experience based on treatment of a large number of septic patients, we have the impression that often gastroparesis is an early sign for the development of sepsis. We did not find any studies that tested this hypothesis.

In this study we would like to investigate whether the development of gastroparesis in critical patients in intensive care can be a predictive sign for the development of sepsis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18--99 who were admitted to the general intensive care unit from January 2015 to April 2021, and who were diagnosed with acquired bacteremia in the ICU (positive blood culture after 48 hours or more from ICU admission). As a control group we will collect data regarding a similar number of patients who were admitted during this time period but were not diagnosed with acquired bacteremia or sepsis during their stay in the unit.

排除标准

  • Patients who did not meet the above criteria or for whom data were missing. Likewise, patients who did not have a nasogastric tube will be excluded (we cannot test gastirc residual volume) as well as patients who were admitted after abdominal surgery (gastroparesis is a common finding in these patients regardless of sepsis and may be a confounder. In addition, acquired bacteremia in these patients could be the result of a surgical complication, such as intra-abdominal sepsis secondary to intestinal leak etc., and gastroparesis usually accompanies abdominal sepsis and will not be the result of sepsis per-se).

结局指标

主要结局

gastroparesis as an early sign for sepsis (bacteremia)

时间窗: 24 hours before appearance of bacteremia

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

sara dichtwald

Dr

Meir Medical Center

研究点 (1)

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