Gradual Versus Immediate Goal-dose Enteral Nutrition in Abdominal Surgery Patients: A Clinical Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 411
- 试验地点
- 1
- 主要终点
- Morbidity of infection
研究概览
简要总结
Patients will be randomized to Gradual or immediate Goal-dose EN group at day 3 after abdominal surgery. Patients will receive Goal-dose EN gradually or immediately after abdominal surgery. Both groups will receive EN for 5 days except 80% of target energy delivered by oral feeding or patients are discharged from hospital. The primary and secondary outcomes will be collected.
详细描述
Patients after abdominal surgery will receive enteral nutrition for 2 days, if she/he can tolerate 30% of goal-dose EN, then she/he will be randomized to Gradual or immediate Goal-dose EN group at day 3. Patients in Gradual Goal-dose EN group will receive increased calories gradually by EN and will reach the 80% of target energy by EN at day 8 while patients in immediate Goal-dose EN group will receive 100% of target energy by EN at day 3 after abdominal surgery. Both groups will receive EN for 5 days except 80% of target energy delivered by oral feeding or patients are discharged from hospital, whichever arrives first. The primary and secondary outcomes will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent of patients or their legal representatives to participate in this study.
- •patients undergoing selective operation without trauma
- •patients following medium or major abdominal surgery
- •NRS 2002≥ 3
排除标准
- •Psychiatric disorders
- •Pregnancy or breast-feeding women
- •Malnutrition
- •Weight loss >10%-15% in 6 months
- •SGA score with stage C
- •Albumin < 30g/L
- •Unstable vital signs or unstable hemodynamics (such as systolic blood pressure < 90 mmHg or mean arterial pressure < 70 mmHg after rapid 500 ml crystal or 200 ml gel infusion, or the 50% increase of vascular active drug infusion rate in an hour, etc)
- •Refuse to participate in the study
- •Mortality rates expected to more than 50% in 6 months with malignant or irreversibility diseases
- •Cancer in terminal stage or
- •HIV positive at end-stage or CD4 < 50/mm3
- •Cardiopulmonary resuscitation (CPR) before cardiac arrest and nervous system function not fully recovery
- •Four levels of physical activity of the patients defined by New York heart association
- •Rely on breathing machine because of chronic diseases
- •Life expectancy less than 24 hours of dying patients
- •Refractory shock to meet any of the following article
- •The infusion rate of dopamine > 15 ug/kg/min
- •The infusion rate of dobutamine > 15 ug/kg/min
- •The infusion rate of epinephrine and norepinephrine > 30 ug/min
- •The infusion rate of phenylephrine > 50 ug/min
- •The infusion rate of milrinone > 0.5 ug/kg/min
- •The infusion rate of vasopressin > 0.04 U/min
- •Inter aortic ballon pump (IABP)
- •Hepatic insufficiency (alanine/aspartate transaminase/bilirubin 200% above normal range)
- •Renal insufficiency(creatinine 200% above normal range)
- •Metabolic diseases（hyperthyroidism/ hypothyroidism, adrenal cortex disorders)
- •EN can not reach 30% of target energy in 48 hours after surgery
- •Burn area exceeding 20% of the patient's body surface
- •Autoimmune diseases or immune dysfunction or history of organ transplantation
- •International standardization ratio (INR) more than 3.0 or platelet count < 30000 cells/mm3 or other hemorrhagic diathesis
- •Intracranial hemorrhage one month before enrolment
- •General contraindications to infusion therapy or history of severe allergy against ingredients of enteral and parenteral nutrition
- •Has already participated in another clinical trial
- •Has started to nutritional support therapy before enrolment
- •Diabetes mellitus (anamnestic and/or under medical treatment)
结局指标
主要结局
Morbidity of infection
时间窗: From date of randomization until the date of infection from any cause, assessed up to 2 months.
Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.
次要结局
- Laboratory examination(At the date of patients enrollment and after intervention, assessed up to 2 months.)
- Length of stay in hospital(From date of operation until the date of patients discharged from hospital, assessed up to 12 months.)
- Mortality(From date of randomization until the date of death, assessed up to 2 months after patients discharged from hospital.)
- Actual calories intake(During the intervention, assessed up to 2 months.)
- Scale the frequency of gastrointestinal intolerance(During the intervention, assessed up to 2 months.)
研究者
Wang Xinying
Professor
Jinling Hospital, China