Comparison of the Effects of Intermittent and Continuous Enteral Feeding on Glucose-Insulin Dynamics in Critically Ill Medical Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Total insulin infused
研究概览
简要总结
Continuous enteral feeding is the most common type of nutrition used in critically ill patients despite being non-physiologic, as all mammalian alimentary tracts have been designed for intermittent ingestion of nutrients. The small numbers of randomized controlled studies that have compared intermittent gastric feeds (IGF) to continuous gastric feeds (CGF) in intensive care units have demonstrated that IGF is safe, feasible and have the shorter time to goal nutrition. Studies of healthy adults have also demonstrated that the mean glucose concentration (MGC) is lowered when bolus enteral feedings are used instead of continuous feeds; these changes in glucose-insulin metrics might be beneficial to a critically ill patient population where stress hyperglycemia is common. This study will compare the effects of CGF and IGF in a critically ill medical patient population. Glucose-insulin dynamics for each type of enteral feed will be analyzed by performing a randomized crossover study to compare the effects of CGF and IGF on MGC, total insulin infused, glucose variability (GV), episodes of hypoglycemia and maximum glucose concentration values.
详细描述
This will be a non-blinded randomized crossover study in a generalized population of critically ill adults. The population of this study is defined from the ages of 18-90 admitted to the Medical Intensive Care Unit (MICU). This study will compare the glucose-insulin dynamics in critically ill adults that are feed using either a CGF or IGF scheme while their glucose concentrations are maintained between 140-180 mg/dl using an insulin infusion protocol. Randomization performed using computer generated random numbers kept individually in sealed envelopes. All participants will have nasal gastric or oral gastric (NG/OG) tube previously placed for their nutritional needs. The amount of Osmolite given will be determined by the ideal weight for each participant: 1.2 cal/ml Osmolite with caloric goal of 25 kcal/kg/day. Feeding intolerance develops which is defined as: excessive abdominal distention, emesis, abdominal pain, vomiting and gastric residual > 250 ml for IGF and gastric residual > 500 ml for CGF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-90 years
- •Anticipated ICU stay greater than 72 hours
- •Expected indication for enteral feeding within first 24-48 hours of ICU admission
排除标准
- •Any contraindications relating to an oral or nasal gastric tube, Osmolite 1.2 cal/ml, goal rate (or goal volume) of Osmolite 1.2 cal/ml using a 24-hour goal nutrition, gastric feeds due to anatomical/physiological pathology, ideal body weight that exceeds 85 kg to maintain goal volumes in the intermittent arm below 301 ml or a potassium greater than 6.
- •Planned procedures or tests that would require holding gastric feeds during the protocol.
- •Pregnancy, confirmed by pregnancy test on all females < 60 years of age.
- •Hemodynamic instability as defined by any vasoactive medication requirement for blood pressure support or cardiac arrhythmias to include: Norepinephrine ≥ 5 mcg/min, Epinephrine ≥ 5 mcg/min, Dopamine > 5 mcg/kg/min, Milrinone 0.375mcg/kg/min, Vasopressin > 0.04 Units/min, Dobutamine > 5 mcg/kg/min, any other vasoactive drip, and any combination of low dose vasopressors listed above. Atrial Nodal blocking agents used in a continuous drip form to include diltiazem, esmolol and amiodarone are allowed if not requiring the above vasoactive medications restrictions.
- •Prior surgical procedure that would preclude a goal rate/or volume for CGF/IGF to include: previous partial or complete gastrectomy or massive intestinal resection leaving less than 200 cm of small bowel.
- •Screening glucose concentration less than 120 mg/dl while NPO unless diabetic.
研究组 & 干预措施
Continuous Enteral Feeding
Crossover Study:
Randomized to continuous enteral feeding first then crossed over to receive versus intermittent enteral feeding next.
干预措施: Comparison of the Effects of Intermittent and Continuous Enteral Feeding on Glucose-Insulin Dynamics in Critically Ill Medical Patients (Other)
Continuous Enteral Feeding
Crossover Study:
Randomized to continuous enteral feeding first then crossed over to receive versus intermittent enteral feeding next.
干预措施: Osmolite 1.2 cal/ml Enteral Feeds (Dietary Supplement)
intermittent enteral feeding
Crossover Study:
Randomized to intermittent enteral feeding first then crossed over to receive versus continuous enteral feeding next.
干预措施: Comparison of the Effects of Intermittent and Continuous Enteral Feeding on Glucose-Insulin Dynamics in Critically Ill Medical Patients (Other)
intermittent enteral feeding
Crossover Study:
Randomized to intermittent enteral feeding first then crossed over to receive versus continuous enteral feeding next.
干预措施: Osmolite 1.2 cal/ml Enteral Feeds (Dietary Supplement)
结局指标
主要结局
Total insulin infused
时间窗: total time in the protocol should be 36 hours to include crossover
Total insulin infused
次要结局
- Mean glucose concentration(time the protocol should be 36 hours to include crossover)
研究者
Tyson Sjulin, D.O.
Pulmonary/Critical Care Fellow
San Antonio Military Medical Center