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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChulalongkorn University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • High protein group

    Other intervention

    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.

  • Standard protein group

    Other intervention

    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

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: High protein groupExperimental treatment 1 intervention
Group B: Standard protein groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in RF-CSA ultrasonography

Change in RF-CSA, as measured by ultrasonography at day 7

Time frame
At day 7 after randomization

Secondary outcomes

1

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

Time frame
At day 28 after randomization
2

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.

Time frame
At day 28 after randomization
3

Change in muscle mass by BIA

measured by bioimpedance analysis at day 7

Time frame
At day 7 after randomization
4

ICU length of stay

the total number of days a patient spends in ICU

Time frame
At day 28 after randomization

Other outcomes

1

Mortality at 28 days and 90 days

Mortality at 90 days

Time frame
28 days and 90 days after randomization
2

Fluid balance at 24 hours, 72 hours and 7 Days

Fluid balance at 24 hours, 72 hours and 7 Days

Time frame
24 hours, 72 hours and 7 Days after Randomization
3

Incidence of any arrhythmia

Incidence of any arrhythmia

Time frame
7 days after randomization
4

Incidence of catheter related bloodstream infection

Incidence of catheter related bloodstream infection

Time frame
7 days after randomization

Sponsors and contacts

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