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NCT Number: NCT07596043

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King chula memorial hospital

Bangkok, 10330, Thailand

Location contact

Nuttha Lumlertgul, MD, PhD

CONTACT

Wiphat Kittiweerawong, MD

CONTACT

[email protected]

0899496165

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

High protein group

Other

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

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

Primary outcomes

  1. Change in RF-CSA ultrasonography

    Time frame: At day 7 after randomization

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

Secondary outcomes

  1. Numbers of RRT-free days at day 28

    Time frame: At day 28 after randomization

  2. Numbers of MV-free days at day 28

    Time frame: At day 28 after randomization

  3. Change in muscle mass by BIA

    Time frame: At day 7 after randomization

    measured by bioimpedance analysis at day 7

  4. ICU length of stay

    Time frame: At day 28 after randomization

  5. Hospital length of stay

    Time frame: At day 28 after randomization

  6. Daily changes in urea levels

    Time frame: From randomization to the end of treatment at 7 days

  7. Incidence of gastrointestinal intolerance

    Time frame: through study completion, an average of 1 month

  8. CPAx

    Time frame: At Randomization and At the end of treatment 7 days

Study contacts

Contact information is provided by the study sponsor or research team.

Wiphat Kittiweerawong, MD

CONTACT

[email protected]

+66899496165

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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)

Acronym: PROTEIN-CRRT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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