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临床试验/NCT03469882
NCT03469882已完成不适用

High Protein Intake and Early Exercise in Adult Intensive Care Patients: Impact on Functional Outcomes. A Randomized Controlled Phase II Trial.

Hospital Sao Domingos2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
2
主要终点
Physical component summary (PCS) 3 months after randomization

研究概览

简要总结

This study analyse the impact of high protein intake associated to early programed exercise on functional outcomes of adult intensive care patients.

详细描述

The muscle weakness associated to intensive care, one of the components of Post Intensive Care Syndrome (PICS) has a significant impact on the short-term and long-term outcomes in the critically ill patient (1, 2). Puthucheary et al. (3) analyzed 63 septic patients with imaging examination and established a clear relationship between the number of organ failures and muscle loss in the first 10 days of ICU. Although a study involving 244 critically ill patients has shown an alarming relationship between reduced muscle mass at admission and mortality (4), evidences that nutritional interventions can attenuate muscle loss and result in improvement in outcome are unclear. Recent studies evaluating the impact of nutritional therapy on clinical outcomes have surprisingly demonstrated that patients who received full nutritional intake did not differ in outcomes when compared to those receiving reduced nutritional intake, the so-called permissive underfeeding (5, 6, 7). Careful analysis of these studies, however, reveals that the authors define hyponutrition as synonymous with reduced calorie intake, without mentioning the protein intake offered to the patients. The study with the greatest scientific repercussion (8) used reduced caloric intake in the study group, but the protein intake did not differ between groups. Observational studies comparing high protein intake with conventional intake have shown improvement in outcome indicators in patients receiving more than 1.6 and even more than 2.0 g / kg / day of protein (9, 10). Recently the intensive care medicine research agenda published in the journal of the European Society of Intensive Care Medicine, the top priority of the nutrition research in the critically ill patients was to compare normal and hyperproteic nutrition ideally associated with physical activity (11). Several recent studies have shown benefits of early physical rehabilitation in the critically ill patient (12, 13).

The optimal integration between adequate protein intake and exercise in the critically ill patient may have an impact on short- and long-term outcomes, but this hypothesis has not yet been tested by studies with a good methodology. The hypothesis of this prospective randomized phase II study is that the association of high protein intake with early physical rehabilitation improves physical function after hospital discharge with a significant impact on quality of life.

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
Single (Outcomes Assessor)

盲法说明

Blinded outcomes assessment

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • We will include 180 consecutive patients admitted to one of the study ICUs
  • Aged 18 years or above.
  • Non-pregnant.
  • Requiring mechanical ventilation for at least 48 hours.
  • Expected ICU stay higher than 3 days.

排除标准

  • Inability to walk without assistance before the acute illness that led to ICU admission (use of gait aid is not an exclusion criterion).
  • Cognitive impairment prior to hospitalization described by relatives and evaluated by the ICU psychology team.
  • Neuromuscular diseases that compromise weaning from mechanical ventilation.
  • Acute pelvic fracture.
  • Unstable spinal cord trauma.
  • Patients considered moribund.
  • In some situations patients will not be included in the resistive exercise program for as long as a temporary limiting factor remains:
  • Patients undergoing neuromuscular blocking drugs.
  • Patients under high-dose vasoactive drug use.
  • Mechanical ventilation with FIO2 (fraction of inspired oxygen) ≥ 60% and / or PEEP (positive end-expiratory pressure)> 12 cm H2O.
  • Intracranial hypertension.
  • . Open abdomen.
  • Status epilepticus.

结局指标

主要结局

Physical component summary (PCS) 3 months after randomization

时间窗: 3 months after randomization

Blind assessment of PCS after 3 months after randomization

Physical component summary (PCS) 6 months after randomization

时间窗: 6 months after randomization

Blind assessment of PCS after 6 months after randomization

次要结局

  • handgrip strength(20 days)
  • Duration of mechanical ventilation(20 days)
  • Length of ICU stay(20 days)
  • Hospital mortality(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

José Raimundo Araujo de Azevedo

MD; PhD

Hospital Sao Domingos

研究点 (2)

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