EUCTR2021-002329-56-ES进行中（未招募）1 期
Exploratory study to evaluate the efficacy and safety of nutritionally administering 1.5 g protein/kg/day vs. 1.0 g protein/kg/day in the catabolic phase of the critically ill patient on mechanical ventilation. - efficacy and safety of administering elevated levels of prOteins to critically ill patients prOteins
Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)0 个研究点目标入组 200 人开始时间: 2021年6月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Must meet all criteria for inclusion:
- •1. Critically ill patient, adult > 18 years of age.
- •2. Admission to the ICU during the previous 48 hours.
- •3.Patients on invasive mechanical ventilation with a minimum expected duration of > 3 days.
- •4.Patient with a minimum expected duration of clinical nutrition of > 7 days from 48 hours after admission.
- •5.Written informed consent from the patient or the patient's legal representative or deferred written consent from the patient or the patient's legal representative.
- •6.Central venous access available for continuous infusion of study drugs.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Refusal of informed consent
- •2. Acute renal failure (renal injury stage of 3)
- •3.Hepatic failure (cirrhosis or Chilg-Pugh Scale > 5).
- •4.Severe hepatic insufficiency with INR > 1.7 (prothrombin time < 50%) and encephalopathy.
- •5.Patients with COVID-19
- •6.Body Mass Index (BMI) > 40 or < 18.5 (morbid obesity or previous caloric malnutrition)
- •7.Pregnant patients
- •8.CNS pathologies (Glasgow < 6)
- •9.Peripheral SN pathologies
- •10.Patients with cognitive dysfunction/dementia or unable to follow instructions regarding MRC tests.
- •11.Severe muscular pathology
- •12.Participation in another clinical trial
- •13.Usual residence outside the region (impossibility of contact after discharge from the ICU).
- •14.Known hypersensitivity to milk protein or to any substance contained in Fresubin®.
- •15.Any congenital error in the metabolism of amino acids.
- •16.Previous inclusion in the present study
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