Evaluation of the Success of Prophylactic Enteral Nutrition in Therapeutic Intensification With Autograft of Autologous Hematopoietic Cells in Hematology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Success rate of enteral feeding
研究概览
简要总结
When the digestive tract is functional, learned societies recommend the use of a nutritional support by enteral feeding. Indeed, it has many advantages (maintenance of gut trophicity, reduction of the risk of infection by reducing the incidence of bacterial translocations,...). It has been used for about fifteen years in hematology departments and offers promising results in the context of allogeneic transplantation with prospective trials in progress (NEPHA study). However, its tolerance has not been studied during autologous transplantation. This study aims to assess the success of enteral nutrition in this setting.
详细描述
In the literature, there are many studies on the nutritional support to be used during allografts, that highlight the superiority of enteral nutrition over parenteral nutrition in terms of reducing co-morbidities.
Enteral nutrition is the nutritional support recommended by learned societies for therapeutic intensification with autograft of autologous hematopoietic cells in hematology. Nevertheless, enteral nutrition presents difficulties in its implementation and failures (refusal of patients, probes vomiting, neutropenic colitis, etc.), requiring the use of parenteral nutrition in case of failure.
In this context, the study proposes to assess the success and effectiveness of enteral nutrition.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with lymphoma or myeloma
- •Patient admitted for therapeutic intensification with autologous hematopoietic cells who are eligible for nutritional support by enteral nutrition
- •Free, informed and written consent signed by the patient
排除标准
- •Refusal of the enteral nutrition
- •All patients with absolute or enteral nutrition contraindications:
- •Digestive fistula
- •Intestinal obstruction
- •Intestinal ischemia
- •Active digestive bleeding
- •Digestive malabsorption (short hail syndrome, bariatric surgery, gastrectomy)
- •Trauma to the base of the skull or significant deviation of the nasal septum not allowing the insertion of an naso gastric probe.
- •Esophagitis or barrett's esophagus
- •Persistent gastro-duodenal dysfunction (gastroparesis)
- •Patients admitted for autograft for the treatment of conditions other than lymphoma or myeloma (e. g. solid tumours or leukaemia)
结局指标
主要结局
Success rate of enteral feeding
时间窗: From admission to recovery from aplasia (or transfer to the intensive care unit or death)
Enteral Nutrition will be considered as a success if : TEI / ER \> 70%. On average until recovery from aplasia (or transfer to the intensive care unit or death). TEI : Total Energy Intake (per-os + enteral nutrition + glucose solutions) ER : Energy Requirement (assessed patient needs)
次要结局
- Number of transfers to the intensive care unit(From admission to discharge (an average of 4 weeks))
- Evolution of total energy intake(Every day from admission to discharge (an average of 4 weeks))
- Weight evolution(From admission to discharge (an average of 4 weeks))
- Type conditioning(On admission, between 1 and 7 days before autologous stem cell transplantation)
- Causes of failure of enteral nutrition(From admission to recovery from aplasia (an average of 3 weeks))
- Evolution of albuminemia(Once a week from admission to discharge (an average of 4 weeks))
- Evolution of muscular strength(From admission to discharge (an average of 4 weeks))
- Duration of hospitalization(From admission to discharge (an average of 4 weeks))
- Number of bacteremia and type of germs(From admission to discharge (an average of 4 weeks))
- Prokinetic and associated antiemetic treatments(From admission to discharge (an average of 4 weeks))