About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Moribund or withholding of treatment
Kidney transplant recipient
Previously diagnosed end-stage kidney disease (ESKD) currently on kidney replacement therapy
Pregnancy or breastfeeding
Trial design
Parallel
Treatments tested in this trial
High protein group
Other interventionPatients 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.
Standard protein group
Other interventionPatients 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
Treatment groups
Trial outcomes
Primary outcomes
Change in RF-CSA ultrasonography
Change in RF-CSA, as measured by ultrasonography at day 7
Secondary outcomes
Numbers of RRT-free days at day 28
Renal replacement therapy-free days (censored at 28 days) is defined as days without RRT at least 3 consecutive calendar days within 28 days after study enrollment
Numbers of MV-free days at day 28
Mechanical ventilator-free days (censored at 28 days) is defined as days free from mechanical ventilation within 28 days after study enrollment. A value of 0 is also allocated if the patient died between inclusion and day 28 or still receiving invasive mechanical ventilation at day 28.
Change in muscle mass by BIA
measured by bioimpedance analysis at day 7
ICU length of stay
the total number of days a patient spends in ICU
Other outcomes
Mortality at 28 days and 90 days
Mortality at 90 days
Fluid balance at 24 hours, 72 hours and 7 Days
Fluid balance at 24 hours, 72 hours and 7 Days
Incidence of any arrhythmia
Incidence of any arrhythmia
Incidence of catheter related bloodstream infection
Incidence of catheter related bloodstream infection
Sponsors and contacts
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