Comparison of Clinical Outcomes According to High-protein Provision in Critically Ill Patients After Abdominal Surgery

Официальное название

Comparison of Clinical Outcomes According to High-protein Provision Through Parenteral Nutrition in Critically Ill Patients Immediately After Abdominal Surgery: a Prospective, Single-blinded, Randomized Controlled Trial

Обзор

Protein malnutrition in critically ill patients is a global concern due to its association with 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, the optimal target of protein supplementation remains controversial. The investigators aimed to evaluate the effects of high protein provision, targeting a protein intake of at least 1.5 g/kg/day for the first 3 days after abdominal surgery, on 6-month mortality.

Подробное описание

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 protein provision 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 vary according to different guidelines, and this is the same for surgical patients. Recent randomized controlled trials reported conflicting results with current guidelines, with some suggesting that higher protein dose administrations did not significantly impact clinical outcomes and may even worsen the outcomes for certain patient groups. Thus, the optimal protein provision target during the acute phase of critical illness, particularly for surgical patients, remains controversial.

The investigators aimed to assess the effects of strict high protein provision between the high protein group (protein target supplemented with 1.5 g/kg/day) and the control group (protein target supplemented with less than 1.5 g/kg/day) using intravenous nutrient solution for the first 3 days after abdominal surgery. Additionally, the investigators investigated the appropriate target for protein provision in critically ill patients who undergo abdominal surgery.

Вмешательства

• Пищевая добавка Active protein supplementation
  The participants in active nutritional supplementation arm received consultation from the nutritional support team (NST) upon ICU admission, and nutritional supplementation was initiated on the same day. NST is a multidisciplinary support team comprised of physicians, nurses, dietitians, and pharmacists, which assesses the nutritional status of patients, and provides recommendations for nutritional therapy. Targets in the participants in active protein supplementation arm were protein supplement
• Пищевая добавка Conventional protein supplementation
  The participants in conventional protein supplementation arm received conservative nutritional management without specific protein targets.

Первичные конечные точки

• 6-month mortality rate [Срок оценки: Participants were followed up to 180 days immediately after the surgery]

Вторичные конечные точки (3)

• 30-day mortality rate [Срок оценки: Participants were followed up to 30 days immediately after the surgery]
• 90-day mortality rate [Срок оценки: Participants were followed up to 90 days immediately after the surgery]
• Incidence of postoperative complications [Срок оценки: Participants were followed during hospitalization (up to 14 days)]

Критерии участия

Критерии включения

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

Критерии исключения

• aged under 18 years
• underwent surgery under local or regional anesthesia
• pregnant
• readmitted to the ICU due to any cause
• diagnosed with renal failure and receiving renal replacement therapy
• patients diagnosed with multiorgan failure, represented by a high Sequential Organ Failure Assessment (SOFA) score (≥9) upon ICU admission
• failed to provide informed consent, or with 'do-not-resuscitate' status.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Division of Trauma and Surgical Critical Care, Department of Surgery, Seoul St. Mary's Hos — Seoul

Идентификаторы

NCT: NCT06458387 · SeoulSt_HP_01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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