Observational and Monocentric Study of Complications in Adults With Cancer Receiving an Artificial Parenteral Nutrition in the Central Vein Initiated in Hospitalization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Prospective assessment of infectious and vascular complications in parenteral nutrition on implanted venous device through systematic registration in relation to care practices
研究概览
简要总结
This observational study will evaluate the frequency of complications in adult cancer patients with central venous parenteral nutrition and the identification of aggravating factors.
详细描述
In oncology, central venous catheters are used for treatments such as chemotherapy, hydration, antibiotic therapy and parenteral nutrition. However, these catheters are responsible for serious complications often infectious or vascular. They can lead to suspension or discontinuation of treatments and can lead to life-threatening outcomes for patients. The incidence rate and risk factors for central venous catheter-related infections in oncology remain poorly known. Recently, a prospective study targeted a 5-fold increase in the risk of catheter infection when parenteral nutrition was associated with chemotherapy.
This is why the indications of parenteral nutrition must be respected and enteral nutrition promoted where possible.
the investigator conducted a retrospective study in 1998 over 10 years and 6 months, including all patients who received or received a parenteral nutrition at home, for at least one month.
Of 153 patients with implantable sites, 181 infectious episodes were recorded in 68 patients (44.4% of the population) with an estimated median infection rate of 2 infections/patients (1-12). There was a clear predominance of community-borne skin germs (85% Staphylococcus sp and 3% multi-resistant bacteria (BMR)).
In order to improve our nursing practices, and reduce complications for patients,the investigator propose the establishment of an observatory of complications in adults with cancer benefiting from superior parenteral nutrition on the central venous tract initiated in hospitalization with a planned return home
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Central venous parenteral nutrition initiated in hospitalization with a planned return home (with parenteral nutrition).
- •Life expectancy > 3 months
- •OMS (World Health Organization) performance status (PS) 0, 1 or 2
- •With initial dietary consultation during hospitalization
- •Age ≥ 18 years
- •Hospitalized 48 hours or more
- •Patient Information and Signature of Informed Consent
- •patient must be affiliated to a French Social Security System
排除标准
- •OMS> 3 or 4
- •Patient in the process of infection
- •Patient followed up in surgery
- •Patient without central vein
- •Patient with superior cave thrombosis,
- •Inability to undergo medical follow-up of the trial for geographical, social or psychological reasons,
- •Terminally ill palliative patient, excluding surgery.
- •Patient whose regular follow-up is not possible due to psychological, family, social or geographical reasons; • Medical or psychological condition which, in the opinion of the investigator, will not allow the patient to complete the study or sign informed consent with full knowledge (Article L.1121-6, L.1121-7, L. 1211-8, L. 1211-9);
结局指标
主要结局
Prospective assessment of infectious and vascular complications in parenteral nutrition on implanted venous device through systematic registration in relation to care practices
时间窗: from date of inclusion visit until an average of 1 year
Number and date of vascular complications per patient
次要结局
- Evaluation of serious complications related to the central vein(from date of inclusion visit until an average of 1 year)
- Evaluation of compliance with protocols for the medical care of infectious and vascular complications(from date of inclusion visit until an average of 1 year)
- Assessment of care practices(from date of inclusion visit until an average of 1 year)
- Evaluation of hospitalizations and central vein ablations(from date of inclusion visit until an average of 1 year)