The Comparison of Effects of Bolus, Intermittent (Nocturnal Pause) and Continuous Enteral Feeding Methods on Blood Glucose and Feeding Intolerance in ICU Patients With Sepsis, Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- effect of enteral feeding methods on blood glucose levels
研究概览
简要总结
Comparison of the effects of bolus, intermittent and continuous enteral feeding techniques on plasma glucose level and enteral feeding intolerance in adult intensive care unit patients with sepsis.
详细描述
in this prospective, controlled trial the main aim is to evaluate the effects of bolus, intermittent and continuous enteral feeding techniques on plasma glucose level in intensive care patients with sepsis diagnosis and to determine whether they are superior to each other in providing norma-glycemia. The secondary aim is to determine the effect of these 3 different enteral feeding techniques on enteral feeding intolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Limitation of the study; since the patients were intubated and under sedation, they did not know the diet applied to them, but the physician/nurse who examined the residue and PGD knew the diet. Unfortunately, the person who evaluated these two parameters could not be blinded, as it would not be possible to give without showing the feeding methods. However, groups 1-2-3 were reported to the statistician who analyzed the data. The feeding methods of the groups was not reported.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized in ICU for more than 3 days
- •Ages between 18-70 years
- •APACHI II is in the range of 8-25
- •BMI in the range of 18.5-30
- •Able to receive enteral nutrition from N/G
- •Intubated on ventilator support
- •No previous diagnosis of Diabetes Mellitus,
- •Those who have not had Gastro intestinal System surgery in the last 6 months
- •Patients not receiving inotropic support
- •not receiving hemodiafiltration
- •No history of allergy to the food used
- •Patients with a focus of infection and/or culture-positive patients diagnosed with sepsis according to Q SOFA (cultures were taken from all patients)
排除标准
- •patient's death during the study
- •Taking more than 40 mg of IV steroids daily
- •Increased baseline APACHI II score
- •Development of the patient's need for inotropes
- •Elimination of inclusion criteria
- •negative culture
研究组 & 干预措施
bolus feeding group
bolus feeding method;The amount of food to be given for 24 hours calculated for the patient was given as 4 equal amounts for 40 minutes at 4 different times. Starting with 150 cc, the target calorie was reached by increasing 100 cc according to the intolerance before the next feeding hour.
干预措施: enteral feeding (Other)
bolus feeding group
bolus feeding method;The amount of food to be given for 24 hours calculated for the patient was given as 4 equal amounts for 40 minutes at 4 different times. Starting with 150 cc, the target calorie was reached by increasing 100 cc according to the intolerance before the next feeding hour.
干预措施: blood glucose measurements (Procedure)
bolus feeding group
bolus feeding method;The amount of food to be given for 24 hours calculated for the patient was given as 4 equal amounts for 40 minutes at 4 different times. Starting with 150 cc, the target calorie was reached by increasing 100 cc according to the intolerance before the next feeding hour.
干预措施: Evaluation of feeding intolerance with gastric residue (Procedure)
intermittent feeding group
The formula was started as 40 cc/h continuous infusion. It was interrupted after 5 hours. 30 minutes after the break, PGD was measured and intolerance was checked, and if the residue was negative, it was increased by 40 cc. The amount was increased until reaching the amount of formula that should be given for 24 hours calculated for the patient. This cycle was repeated 3 times in 24 hours. At 24:00, it was stopped and feeding was interrupted between 24:00 and 06:00.
干预措施: enteral feeding (Other)
intermittent feeding group
The formula was started as 40 cc/h continuous infusion. It was interrupted after 5 hours. 30 minutes after the break, PGD was measured and intolerance was checked, and if the residue was negative, it was increased by 40 cc. The amount was increased until reaching the amount of formula that should be given for 24 hours calculated for the patient. This cycle was repeated 3 times in 24 hours. At 24:00, it was stopped and feeding was interrupted between 24:00 and 06:00.
干预措施: blood glucose measurements (Procedure)
intermittent feeding group
The formula was started as 40 cc/h continuous infusion. It was interrupted after 5 hours. 30 minutes after the break, PGD was measured and intolerance was checked, and if the residue was negative, it was increased by 40 cc. The amount was increased until reaching the amount of formula that should be given for 24 hours calculated for the patient. This cycle was repeated 3 times in 24 hours. At 24:00, it was stopped and feeding was interrupted between 24:00 and 06:00.
干预措施: Evaluation of feeding intolerance with gastric residue (Procedure)
continous feeding group
The same method was applied as in Group 2. However, after 24:00, feeding was not interrupted and continued as the 4th cycle.
干预措施: enteral feeding (Other)
continous feeding group
The same method was applied as in Group 2. However, after 24:00, feeding was not interrupted and continued as the 4th cycle.
干预措施: blood glucose measurements (Procedure)
continous feeding group
The same method was applied as in Group 2. However, after 24:00, feeding was not interrupted and continued as the 4th cycle.
干预措施: Evaluation of feeding intolerance with gastric residue (Procedure)
结局指标
主要结局
effect of enteral feeding methods on blood glucose levels
时间窗: for 7 days after the start of feeding
Evaluation of hypo/hyperglycemia development by measuring blood glucose level 4 times a day
次要结局
- feeding intolerance(during the 7th day with the start of feeding)
研究者
Senay Goksu
SPECIALIST, MD, Principal Investigator, Principal Assistant
Umraniye Education and Research Hospital