Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- KU Leuven
- 入组人数
- 4,640
- 试验地点
- 3
- 主要终点
- Length of stay in ICU and length of stay in the hospital.
研究概览
简要总结
In critically ill patients, a strategy aimed at an early delivery of full caloric support, with a combination of Enteral Nutrition (EN) and Parenteral Nutrition (PN) (in conditions preventing hyperglycemia and overfeeding), results in shorter ICU and hospital stay and less morbidity as compared to a strategy using only EN.
详细描述
Written informed consent will be obtained from the patient or the closest family member or legal guardian. The family member or the patient can withdraw from the trial, at any time, without impact on his treatment or penalty. The investigators confirm that this study concerns a condition that directly threatens patient health and that the adult patient not able to give consent suffers from the condition. The experiment is essential to confirm the results from earlier research in patients who could consent or from other research methods.
On admission patients will be randomly assigned to receive EN combined with early PN or only EN. At ICU admission, consecutive patients will be randomly assigned to one of these two treatment groups using blinded envelopes, stratified according to primary diagnostic category on admission. Upon addition of the new study site, the numbered en sealed envelopes for randomization stratified according to primary diagnostic category on admission were replaced by an identical digital system allowing central randomization.
As initial nutritional support, patients randomised to the 'EN combined with early PN' group will receive glucose 20% at 40 ml/hr. EN will be initiated in the evening of the second ICU hospitalisation day, PN will be started the morning of the third ICU hospitalisation day. The amount of PN to be given on any particular day will be the difference between calculated caloric needs and the calories delivered by EN the previous 24 hours. When EN covers 80% of calculated caloric needs PN will be stopped. When the patient is able to eat, the parenteral regimen will be reduced and eventually stopped. Whenever oral (+ enteral) intake is below 50% of calculated caloric needs, the PN will be (re)-started.
As initial nutritional support, patients randomised to the 'EN only' group will receive glucose 5% at 40 ml/hr. EN will be initiated on the evening of the second ICU day. From the morning of the third ICU hospitalisation day on, the amount of glucose 5% to be given will be the same as the volume of PN the patient theoretically would require to receive 100% of presumed caloric needs based on the amount of EN delivered the previous 24 hours. When the patient is able to eat, the parenteral regimen (glucose 5%) will be reduced to 50% and eventually stopped. Whenever oral (+ enteral) intake is below 50% of calculated caloric needs, the PN (glucose 5%) will be (re)-started. If these patients would need to stay for more than seven days on the ICU and enteral feeding of at least 80% of the calculated calories is not possible, they will be switched to EN and PN on day eight.
Common strategy for attempting early enteral nutrition in both study arms:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
All outcome adjudicators were unaware of study-group assignments
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to any of the five intensive care units
- •Older than 18 years
- •Nutritional risk screening score (NRS) higher or equal to three upon ICU admission
排除标准
- •Patients with a do not resuscitate (DNR) code or moribund at the time of ICU admission
- •Patients already enrolled in another trial
- •Patients transferred from another intensive care unit with an established nutritional therapy
- •Patients suffering from ketoacidotic or hyperosmolar coma on admission
- •Patients with a body mass index (BMI) below 17 kg/m^2
- •Short bowel syndrome
- •Patients known to be pregnant or nursing
- •Patients on mechanical ventilation at home
- •NRS score lower than three
- •Patient readmitted to ICU after randomization to the EPaNIC trial.
- •Patient not critically ill on admission. (No clinical indication for central intravenous catheter or patient ready for oral nutrition on admission.)
研究组 & 干预措施
EN only
Withholding PN during the first week of ICU stay
干预措施: Withholding PN during the first week of ICU stay (Other)
EN plus early PN
Oliclinomel N71000 OR N71000E // Clinimix N17G35 OR N17G35E Parenteral nutrition targeted at covering calculated needs together with the enteral nutrition intake that is achieved
干预措施: Oliclinomel N71000 OR N71000E // Clinimix N17G35 OR N17G35E (Drug)
结局指标
主要结局
Length of stay in ICU and length of stay in the hospital.
时间窗: 2 years
次要结局
- Blood lipid profiles and albumin on days one, five, ten, and fifteen after admission(2 years)
- Days to weaning from mechanical ventilation(2 years)
- The presence or absence of hyper-inflammation within five days after ICU admission(2 years)
- The need for renal replacement therapies(2 years)
- The presence or absence of new kidney injury during intensive care(2 years)
- The need for tracheotomy(2 years)
- Days of vasopressor or inotropic support(2 years)
- The presence or absence of signs of ICU liver disease: hyperbilirubinemia (defined as bilirubin level > 3 mg/dl), presence of liversteatosis, sludge…(2 years)
- Amount and type of calories delivered(2 years)
- Muscle strength: among others: MRCss, Maximum Inspiratory Pressure in patients staying more than 7 days in ICU and a subset staying < 7 days, as well as in individuals who have never stayed in ICU. Presence of electrophysiological signs of CIP/CIM.(10 years)
- Rehabilitation/functionality: among others: six minute walking distance and activities of daily life at hospital discharge and at follow-up moments. SF 36 questionnaire at several follow-up moments and in individuals who have never stayed in ICU.(10 years)
- Death (hospital and ICU mortality and 90 days mortality)(10 years)
- The presence or absence of bacteraemia, ventilator-associated pneumonia and of wound infections(2 years)
- Episodes of hypoglycaemic events (defined as glycemia less than 40 mg/dl)(2 years)