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临床试验/NCT06058247
NCT06058247已完成不适用

Reducing In-Hospital and 60-Day Mortality in Critically Ill Patients After Surgery With Strict Nutritional Supplementation: A Prospective, Single-Labeled, Randomized Controlled Trial

Seoul St. Mary's Hospital2 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2019年3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
368
试验地点
2
主要终点
60-day mortality rate

研究概览

简要总结

Malnutrition in critically ill patients is a global concern due to its association with increased infectious complications, prolonged hospital stays, and higher morbidity rates. Patients who undergo abdominal surgery are particularly vulnerable due to alterations in gastrointestinal function and prolonged fasting. Despite the significance of proper nutrition, guidelines remain broad, and practical implementation is often inadequate.

The investigators aimed to assess the effects of strict nutritional provision, targeting an energy adequacy of 80% or more and a protein intake of at least 1.5 g/kg/day, on in-hospital and 60-day mortality.

详细描述

During the acute phase of critical illness, patients experience metabolic and physiological changes that affects their nutrition status. One prominent feature is the activation of stress hormones and inflammatory mediators, which contribute to a negative nitrogen balance, increased gluconeogenesis, and accelerated muscle proteolysis. Among these patients, those who undergo abdominal surgery are particularly vulnerable to malnutrition as they experience alterations in the structural barrier of the gastrointestinal tract, impaired nutrient absorption, and prolonged fasting due to concerns such as the integrity of an anastomosis. Thus, appropriate nutritional therapy should be prioritized for critically ill patients following abdominal surgery, and it should include adequate nutritional support to preserve lean body mass and organ function.

Despite the importance of nutritional supply, the recommendations for protein or calorie intake vary according to different guidelines, and this is the same for surgical patients. Additionally, some patients experience a delay in initiating nutritional support, and several studies reported that only 39 - 63% of the intended energy and 45 - 55% of the prescribed protein are being administered to critically ill patients during the acute phase. Furthermore, recent randomized controlled trials reported conflicting results with current guidelines, with some suggesting that lower calorie or higher protein dose administrations did not significantly impact clinical outcomes and may even worsen the outcomes for certain patient groups. Thus, the optimal nutritional provision target during the acute phase of critical illness, particularly for surgical patients, remains controversial, and there is no standardized protocol.

In our previous study, the malnutrition status upon admission, indicated by a modified Nutrition Risk in the Critically Ill (mNUTRIC) score of 5 or higher, and low energy adequacy during intensive care unit (ICU) stay were identified as mortality predictors in critically ill patients following abdominal surgery. The investigators aimed to assess the effects of strict nutritional provision, targeting an energy adequacy of 80% or more and a protein intake of at least 1.5 g/kg/day, on in-hospital and 60-day mortality. Additionally, the investigators investigated the appropriate target for nutrition support in critically ill patients who undergo abdominal surgery.

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 (Participant)

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

  • Patients admitted after abdominal surgery to our institution's surgical ICU
  • They were enrolled regardless of the surgical method, either open, laparoscopy, or robotic.

排除标准

  • aged under 18 years
  • underwent surgery under local or regional anesthesia
  • readmitted to the ICU
  • diagnosed with renal failure and receiving renal replacement therapy
  • lacked individual data necessary to calculate the mNUTRIC score measured at ICU admission
  • failed to provide informed consent, or with 'do-not-resuscitate' status.
  • the patient was discharged or expired within 48 hours of ICU admission
  • patients diagnosed with multiorgan failure, represented by a high Sequential Organ Failure Assessment (SOFA) score (≥9) upon ICU admission

结局指标

主要结局

60-day mortality rate

时间窗: Participants were followed upto 60th day after surgery

Proportion of patients who died within 60 days after surgery among participants

次要结局

  • In-hospital mortality rate(Participants were followed upto 60th day after surgery)
  • Incidence of postoperative complications(Participants were followed upto 60th day after surgery)

研究者

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

Eun Young Kim

Professor

Seoul St. Mary's Hospital

研究点 (2)

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