Achieving nuTritional Target in criticAlly Ill patieNts With iMpairEd gastroiNtesTinal Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Differences in the attainment (in percentage) of daily calorie
研究概览
简要总结
Clear study hypothesis / research question
It has already been proven that a prolonged negative energy balance during intensive care stay is an independent risk factor for mortality. Although it was thought that achivieng optimal delivery of calories will prevent nutritional deficits in critically ill patients, published randomized controlled trials failed to confirm this hypothesis.
Combinging enteral and parenteral support may be an efficent strategy to reach nutritional target in critically ill patients. According to the current guidelines the use of suplemental parenteral nutrition (SPN) should be considered when energy targets are not achieved by enteral (EN) route, however, no clear data regarding timing, amount and composition is specified. Moreover, based on recente published data overfeeding should also be avoided, considering the negative impact on outcome.
Nutritional support for critically ill patients was focused more on preventing caloric and protein deficits and no great emphasis was placed on the efficiency of intestinal absorption. Gastrointestinal dysfunction is a prevalent reported complication that may contribute to falling short of meeting nutritional goals. This encompasses a wide spectrum of symptoms, such as impaired gastric emptying, ileus or impaired intestinal absorbtion, exposing patients to feeding intolerance, malnutrition and worse outcomes. No standard definition and monitoring techniques are so far available for the diagnostic of feeding intolerance. Although increased gastric residual volume (GRV) is the most used parameter for highlighting feeding intolerance, a controversy regarding the adequate threshold of GRV persists. Acetaminophen absorption test has been previously proposed as a diagnostic tool to asses impaired gastric emptying and intestinal absorbtion.
Besides intestinal absorbtion, efficient utilization of macronutients should also be assessed, considering that critically ill patients have varying metabolic conditions and may not be able to metabolically handle adminsitered substrates. As a result body composition analysis should be taken into account in order to obtain a dynamic quantification, especially, of the mucle mass compartiments.
Therefore the following low-interventional study is designed to investigate the hypothesis regarding energy and protein intake achievement in critically ill patients with diagnosed impaired gastrointestinal dysfunction to whom tailored nutritional support is administered.
Taking into account that we aim to identify patients with early-phase gastrointestinal dysfunction impaired gastric emptying and reduced intestinal absorbtion (diagnosed using ultrasound gastric residual volume and byacetaminiphen absorbtion test) will serve as defining factors. Patients will be randomized to receive nutritional support either according to the EN protocol or enteral trophic feed + SPN protocol.
Differences in rectus femoris thickness measured on admission, on day 10 and 15, variation of lean body mass measured by bioelectrical impedance on admission on day 10 and 15, and differences between groups in muscle function using handgrip dynamometer will also be evaluated in both groups.
详细描述
Rationale and clinical significance of the hypothesis
It has already been stated that nutritional support represents a crucial component in the care of critically ill patients. High metabolic demand encountered for critically ill patients may cause significant energy deficits responsible for increased risk of infection, prolonged mechanical ventilation and ICU stay. Aditionally, providing nutritional support in ICU patients is often deeemd challenging, as enteral feeding intolerance devolps secondary to gastrointestinal dysfunction. Although some authors opinioned that reducing energy targets might be beneficial, several studies proved that permissive underfeeding has no positive impact on outcome. Morover, reduction of energy target recommendation was associated with a scondary decrease of protein supplementation.
Apart from disscussing nutritional intake, great emphasis should be placed on nutritional uptake as an increased percentage of critically ill patients fail to reach nutritional targets often due to gastrointestinal dysfunction.
Gastrointestinal dyfunction may be defined by a variety of functional impairements affecting motility, absorbtion, microbiome composition or perfusion, but still, at this momement there is a lack of recommendation regarding monitoring methods[6]. At the bedside, assesement of gastrointestinal dysfunction often relies on measuring GRV. However, gastric emptying rate proved to be poorly correlated with GRV. This monitoring technique may also result in a decresed amount of nutrients delivery. Since ultrasound has became a popular diagnostic tool also in the ICU, several studies indicated that ultrasonographic measurement of gastric antral cross-sectional area has a good correlation with both aspirated GRV and gastric volume measured by computerised tomography. Considering that paracetamol has little to no absorption in the stomach and is completely absorbed at the intestinal level, paracetamol absorption test (PAT) has been proposed as a simple, indirect method for evaluating gastric emptying. As the pharmacokinetic studies have established that gastric emptying is a rate-limiting step for paracetamol absorbtion, studies where PAT was used, validated a significant correlation with scintigraphy results.
The combination of reduced tolerance to enteral feeding at the initiation of nutritional support, along with the initiation of nutritional support within 48 hours, has been proven to be responsible for a progressively significant and intractable energy deficit. It has been found that continuing enteral feeding under these circumstances is ineffective in resolving this energy debt which is proportional with an increased risk of nosocomial infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •All adults (> 18 years old)
- •Mechanical ventilation for more than four days,
- •Controlled shock state (hemodynamic and tissue perfusion goals are reached) - Impaired intestinal absorbtion, defiend by both ultrasound measurement of gastric residual volume and paracetamol absorbtion test
排除标准
- •patients on non-invasive mechanichal ventilation
- •contraindication for EN for > 48 h after admission
- •patients with gastrointestinal surgical intervention within 3 months,
- •history of malabsorption, inflammatory bowel disease
- •short bowel syndrom
- •anorexia nervosa
- •gastrointestinal bleeding
- •cirrhosis
- •traumatic brain injury
- •subarahnoidal hemorrhage
- •neoplasia
- •post cardiac arrest patients
- •patients on chronic therapy with corticosteroids
- •pregnant women.
研究组 & 干预措施
EN group
enteral nutrition intake will progressively be increased according to the gastrointestinal tolerance (evaluated based on ultrasound guided gastric residual volume measurement) until the target of 100% is attained following admission to the ICU.
Supplemental parenteral nutrition (SPN) group
gradually initiate supplemental parenteral nutrition in order to achieve the target of 80% by the fifth day. Trophic feed will be administered to cover the remaining 20% of the targeted nutrition intake.
干预措施: Supplemental Parenteral Nutrition (SPN) (Dietary Supplement)
结局指标
主要结局
Differences in the attainment (in percentage) of daily calorie
时间窗: day 15
Differences in the attainment (in percentage) of daily calorie pre-set targets\* calculated from the rest energy expenditure measured (mREE) using indirect calorimetry (IC) between the EN and SPN groups. \*pre-set targets are defined according to the described nutritional protocol (see below Section e. Nutritional protocol) as 25 % of the energy target determined by indirect calorimetry by day 2, 50% by day 3 to 4 and 75 % at day 4. After day 4 the pre-set target is gradually increased to 100 %.
Differences in the attainment (in percentage) of daily protein
时间窗: day 15
Differences in the attainment (in percentage) of daily protein pre-set targets\* calculated from the rest energy expenditure measured (mREE) using indirect calorimetry (IC) between the EN and SPN groups. \*pre-set targets are defined according to the described nutritional protocol (see below Section e. Nutritional protocol) as 25 % of the energy target determined by indirect calorimetry by day 2, 50% by day 3 to 4 and 75 % at day 4. After day 4 the pre-set target is gradually increased to 100 %.
次要结局
- Variation of phase angle between two groups(day 15)
- Variation of lean body mass measured by bioelectrical(day 15)
- Mortality(on day 28)
- blood glucose concentration(on day 15)
- Differences in rectus femoris thickness measured on admission, on day 10 and 15(day 15)
- muscle force measured on day 15(day 15)
- protein adequacy(day 15)
- ureea/creatinine ratio(on day 15)
- energy adequacy(day 15)
- insulin rate(day 15)
研究者
Cristian Cobilinschi
Principal Investigator, MD, PhD,
Romanian Society for Enteral and Parenteral Nutrition