Effect of High Versus Standard Protein Intake in Critically Ill Patients With Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

Официальное название

Effect of High Versus Standard Protein Intake in Critically Ill Patients With Acute Kidney Injury Requiring Continuous Renal Replacement Therapy: A Randomized Controlled Trial (PROTEIN-CRRT)

Обзор

During critical illness, patients experience a hypercatabolic state. This hypercatabolic state causes muscle wasting in patients, resulting in intensive care unit acquired weakness (ICU-AW). ICU-AW is associated with prolonged mechanical ventilation (MV) weaning, extubating failure and extended length of stay. Previously recognized risk factors for ICU-AW include shock, sepsis, multiple organ failure, hyperglycemia, and prolonged exposure to corticosteroids, sedatives, or paralytic agents. Critical illness is complicated by the development of acute kidney injury (AKI). AKI causes muscle wasting by increasing protein degradation and decreasing protein synthesis. Furthermore, patients with severe AKI often require renal replacement therapy (RRT), which contributes to additional protein loss. Studies have estimated that amino acid losses associated with RRT may range from 5 to 19 g/d, with greater losses observed in patients undergoing continuous renal replacement therapy (CRRT). AKI requiring CRRT has recently been proposed to contribute to an increased risk of ICU-AW. Therefore, critically ill patients with AKI may require increased protein intake to compensate for these metabolic alterations. However, higher protein intake, particularly during the early acute phase of critical illness, may be associated with prolonged need for RRT or delayed kidney recovery. The objective of this trial is to compare the effects of a high protein intake versus a standard protein intake on muscle mass change in critically ill patients with AKI requiring CRRT. The goal of this clinical trial is to learn if high protein intake (1.5-1.7 g/kg/d) can reduce ICU associated weakness in critically ill patients with AKI requiring CRRT. The main questions it aims to answer is: • Does High protein intake (1.5-1.7 g/kg/d) reduce the change in RF-CSA, as measured by ultrasonography at day 7 in critically ill patients with AKI requiring CRRT Researchers will compare drug high protein intake to standard protein intake to see if high protein intake effect on muscle mass by ultrasonography. Participants will: * Receive high protein group (1.5-1.7 g/kg/d) in High protein group and standard protein intake (1.0-1.2 g/kg/d) in control group for 7 days * Rectus femoris ultrasonography was performed twice on day 1 and day 7

Вмешательства

• Другое High protein group
  Patients will receive enteral nutrition via feeding tube. The nutrition provided is a medical nutrition formula with a protein proportion of 7.5 g/100 kcal with caloric content 1.2 kcal/ml.
• Другое Standard protein group
  Patients will receive enteral nutrition via feeding tube. The nutrition provided is a medical nutrition formula with a protein proportion of 5 g/100 kcal with caloric content 1.2 kcal/ml

Первичные конечные точки

• Change in RF-CSA ultrasonography [Срок оценки: At day 7 after randomization]

Вторичные конечные точки (8)

• Numbers of RRT-free days at day 28 [Срок оценки: At day 28 after randomization]
• Numbers of MV-free days at day 28 [Срок оценки: At day 28 after randomization]
• Change in muscle mass by BIA [Срок оценки: At day 7 after randomization]
• ICU length of stay [Срок оценки: At day 28 after randomization]
• Hospital length of stay [Срок оценки: At day 28 after randomization]
• Daily changes in urea levels [Срок оценки: From randomization to the end of treatment at 7 days]
• Incidence of gastrointestinal intolerance [Срок оценки: through study completion, an average of 1 month]
• CPAx [Срок оценки: At Randomization and At the end of treatment 7 days]

Критерии участия

Критерии включения

• Adult (≥18 years old)
• AKI receiving CRRT within 7 days after ICU admission
• Achieve and tolerate calories 70% of target daily caloric requirement (20 kcal /kg/d) within 7 days after ICU admission by enteral feeding
• Participant or their surrogates is willing and able to give informed consent for participation in the study

Критерии исключения

• Moribund or withholding of treatment
• Kidney transplant recipient
• Previously diagnosed end-stage kidney disease (ESKD) currently on kidney replacement therapy
• Pregnancy or breastfeeding
• Hepatic encephalopathy (West Haven grade 3-4)
• Burn patients
• Patients whom the responsible clinician felt that the patient either needed low or high protein
• Severe complications of diabetes such as ketoacidosis, hyperosmolar coma
• Had pre-existing neuromuscular disorders
• Previously leg amputations

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Таиланд · 1 центр

• King chula memorial hospital — Bangkok

Идентификаторы

NCT: NCT07596043 · 0306/69

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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