Influence of Early vs Late Supplemental ParenteraL Nutrition on Long-term Quality of Life in ICU Patients After Gastrointestinal Oncological Surgery. A Prospective, Randomised, Multi-centre Assessor-blinded Study. hELPLiNe Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- Long-term quality of life at 3 months
研究概览
简要总结
BACKGROUND: Nutrition plays a significant role in ICU treatment, and may influence mortality and length of stay in ICU. Enteral route (EN) is preferential to parenteral route (PN) in provision of daily nutritional requirements. When enteral route is insufficient, supplemental parenteral nutrition (SPN) is recommended. Optimal timing of SPN in acute phase of illness remains elusive. ICU patients suffer significant lean body mass loss, in majority, in the first 7-10 days of stay. Optimal provision of protein may prevent muscle wasting. Lean body mass is essential for optimal physical functioning after treatment. Although ICU mortality has been reduced lately, the number of patients going to rehabilitation after ICU stay has tripled. Patients after oncological surgery of the gastrointestinal tract may be threatened with impairment of physical functioning after ICU treatment.
AIM: To compare the influence of early and late supplemental parenteral nutrition on long-term physical functioning in ICU patients after oncological surgery of the gastrointestinal tract.
STUDY DESIGN: Prospective, randomised, multi-centre assessor-blinded study. METHODS & ANALYSIS: Patients will be randomised into intervention group that would receive SPN on first day, and would be continued until 7th day of stay in ICU. Control group would receive SPN on 7th day of stay in ICU, when it is not then already met via enteral route. Physical Component of SF-36 Scale at 6 month after ICU admission will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •ICU patients in the acute phase of critical illness after gastrointestinal oncological surgery.
- •Admitted to the ICU during the previous 24 hours with a minimum expected ICU stay of ≥5 days
- •Central venous access available for continuous infusion of the study drugs
- •Sequential Organ Failure Assessment (SOFA) score ≥2
- •Written informed consent from the patient or the patient's legal representative
排除标准
- •Contraindication against SPN or inability to receive SPN via central venous access
- •Received PN within 7 days before randomisation
- •Expected to receive ≥20% of energy via supplemental enteral nutrition (EN) and/or non-nutritional sources (e.g. glucose solution for drug dilution or lipids from propofol) during the first 3 nutritional treatment days
- •Inability to initiate EN prior to randomization
- •Body mass index (BMI) <17 kg/m2 or >35 kg/m2
- •Any severe, persistent blood coagulation disorder with uncontrolled bleeding
- •Any congenital errors of amino acid metabolism
- •Known hypersensitivity to fish, egg, soybean proteins, peanut proteins, or to any of the active substances or excipients contained in SPN.
- •Known hypersensitivity to milk protein or to any other substance contained in SPN
- •Acute liver failure with encephalopathy, including intoxication (e.g. paracetamol, death cap, golden chain) and/or liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma glutamyl transferase [GGT]) or bilirubin exceeding 10 x ULN
- •Hemophagocytic syndrome
- •Known history of human immunodeficiency virus (HIV), hepatitis B and/or C
- •Pregnancy or lactation
- •Patient unlikely to survive to 6 months due to underlying illness
- •Receiving end-of-life-care
- •Laboratory Exclusions:
- •Hypertriglyceridemia characterised by serum triglyceride levels >4 mmol/L [>350 mg/dL])
- •Treatment-refractory, clinically significant major abnormality in the serum concentration of any electrolyte (sodium, potassium, magnesium, total calcium, chloride, inorganic phosphate)
- •Concomitant Therapy Exclusions:
- •Chronic maintenance therapy with systemic glucocorticoid steroids (Hydrocortisone >0.3 mg/kg/d)
- •Concomitant administration of chemotherapy
- •Administration of growth hormone and teduglutide within the previous 4 weeks
- •Other Exclusions:
- •Chronic liver failure ( Child -Pugh scale B or C) e.g. secondary to drug or alcohol abuse
- •Participation in another interventional clinical trial within the previous 4 weeks
- •Previous inclusion in the present study
研究组 & 干预措施
Late Supplemental Parenteral Nutrition
Control group: would receive EN reaching up to 20 % of daily nutritional requirements and late (of up to 80%) of protein (2 g/kg/ day or in case of CRRT 2,5 g/kg/ day) and caloric (15-20 kcal/kg/day ) in SPN on 7th day of stay in ICU if it is not already met via enteral route.
Early Supplemental Parenteral Nutrition
Intervention group: would receive EN reaching up to 20 % of daily nutritional requirements and early (on first day of stay in ICU) provision (of up to 80%) of protein (2 g/kg/ day or in case of continuous renal replacement therapy (CRRT) 2,5 g/kg/ day) and caloric (15-20 kcal/kg/day) needs in SPN that would be continued until 7th day of stay in ICU for the purpose of the study.
干预措施: Early Supplemental Parenteral Nutrition (Procedure)
结局指标
主要结局
Long-term quality of life at 3 months
时间窗: Physical component of 36 -SF questionnaire at 3 months after admission to ICU
Long-term quality of life measured in physical component of 36 -SF questionnaire
Long-term quality of life at 6 months
时间窗: Physical component of 36 -SF questionnaire at 6 months after admission to ICU
Long-term quality of life measured in physical component of 36 -SF questionnaire
次要结局
- Insulin dose(For 7 days since admission to ICU)
- Mechanical Ventilation(For 28 days since admission to ICU or till discharge)
- Thickness of diaphragm(1st, 3rd, 5th day of ICU stay)
- Protein delivery(For 7 days since admission to ICU)
- Blood glucose profile(For 7 days since admission to ICU)
- Organic phosphorus level(For 7 days since admission to ICU)
- ICU mortality(For 28 days since admission to ICU or till discharge)
- Hospital mortality(For 28 days since admission to ICU or till discharge)
- Health-care associated infection(For 28 days since admission to ICU or till discharge)
- Length of stay in the ICU(For 28 days since admission to ICU or till discharge)
- Sequential Organ Failure Assessment score ( SOFA score)(For 28 days since admission to ICU or till discharge)
- Length of stay in hospital(For 28 days since admission to ICU or till discharge)
- Energy Intake(For 7 days since admission to ICU)
- Antibiotic-free days(For 28 days since admission to ICU or till discharge)
- Enteral route intolerance(At day 3 since admission to ICU)
研究者
Paweł Piwowarczyk
Principal Investigator
Medical University of Lublin