The Influence of Diluted and Undiluted Enteral Nutrition on Nutritional Tolerance in Critically Ill Patients After Gastrointestinal Surgery - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Number of participants having diarrhea
研究概览
简要总结
Adult patients after elective major abdominal surgeries who are planned to be admitted to the Intensive Care Unit (ICU) can be included in the trial.
Each patient will be fed via the gastrointestinal tract. Half of the patients will receive enteral nutrition (EN) with additional fluids, and the rest will receive undiluted EN.
The primary aim of this study is feeding intolerance assessment in both groups of patients.
详细描述
Approximately 50 % of the intensive care unit (ICU) population has feeding intolerance (FI), which includes nausea, vomiting, diarrhea, and others. Some studies suggest that FI can be alleviated in patients fed with supplemental parenteral nutrition (PN).
Adult patients after elective major abdominal surgeries who are planned to be admitted to the ICU can be included in the trial.
After the ICU admission, the patient will be stabilized, including warming, correction of water, electrolyte, and acid-base disorders, and blood transfusion if required. The fluid therapy will be monitored using the transpulmonary dilution technique.
Then, an attending physician will contact an investigator. The investigator will decide about the randomization (no contraindication). The investigators plan to maintain fluid therapy with continuous Glucose-Na-K Baxter 50 mg/ml solution for infusion (GNAK). GNAK will be administered in the same flow as EN, enterally or intravenously (i.v.).
Patients will be randomized to one of two studied groups:
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 (Participant)
盲法说明
The patient will not be aware of the allocation
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
- •Scheduled for major abdominal surgery requiring ICU admission
- •Having access to the GI tract (gastric or jejunal)
- •Planned to be fed enterally
排除标准
- •Patients unable to give informed consent
- •After emergency surgeries
- •Without access to the GI tract
- •Individuals with contraindications to EN, such as short bowel syndrome, uncompensated shock, acidosis (pH < 7.1; lactate > 5 mmol/l), bleeding from the upper GI tract, obstruction, intestinal ischemia, abdominal compartment syndrome
- •Patients with symptomatic gastro-esophageal reflux
- •Expected ICU stay < 3 days
- •Pregnancy and lactation
结局指标
主要结局
Number of participants having diarrhea
时间窗: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Incidents of diarrhea (≥ three loose stools per day)
Number of participants having nausea and vomiting
时间窗: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Incidents of nausea and vomiting (nausea measured with a 4-point verbal descriptive scale (0=no nausea, 1=mild, 2=moderate, 3=severe))
Number of participants having increased gastric residual volume
时间窗: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Increased gastric residual volume (\> 500 ml of gastric aspirate/ 6 hours). Only in patients after lower GI tract surgeries (with intact stomach and gastric feeding)
Number of participants in whom target EN will not be achieved
时间窗: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Achieving target EN on day three and later: 80% of protein requirements according to ESPEN (1.3/kg of ideal body weight (patients BMI \< 30) or adjusted body weight, BMI ≥ 30)
Number of participants in whom prokinetic agents will be used
时间窗: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Administration of prokinetic agents according to the intensivist discretion. Starting with both erythromycin (125 mg twice daily enterally) and metoclopramide (10mg three times per day i.v.)
次要结局
- Sequential Organ Failure Assessment Score (SOFA)(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Electrolyte supplementation(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Intensive care unit (ICU) stay(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Intestinal fatty-acid binding protein (I-FABP)(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Insulin consumption(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Contribution of PN in total nutrition(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Intraabdominal pressure(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Blood products transfusion(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Vasoactive drugs(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Stroke volume variation(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Ketones(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Days of support with PN(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Enteral access obstruction(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Fluid balance(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Acute kidney injury (AKI)(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Complete blood count (CBC)(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Antibiotics(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- C-reactive protein (CRP)(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Procalcitonin (PCT)(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Hospital stay(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Zonulin(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Cardiac output(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Extravascular lung water(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Lactates(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Blood proteins(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Infection site(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Mechanical ventilation(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Quality of recovery(30 days after randomization)
- Systemic vascular resistance(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Blood albumins(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Hospital mortality(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
- Microbiome(From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first)
研究者
Michał Borys
associate professor
Medical University of Lublin