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

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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Continuous Renal Replacement Therapy (CRRT); Acute Kidney Failure Stage 3
• Intervention / Treatment: Other: High protein group; Other: Standard protein group

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wiphat Kittiweerawong, MD; Phone Number: +66899496165; Email: inter.wiphat@gmail.com

Study Locations

• Thailand
  • Bangkok
    • Bangkok, Bangkok, Thailand, 10330
      • King chula memorial hospital
      • Contact: Nuttha Lumlertgul, MD, PhD
      • Contact: Wiphat Kittiweerawong, MD; Phone Number: 0899496165; Email: inter.wiphat@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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. Deliverd protein 1.5-1.7 g/kg/d.	Other: 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.
Active Comparator: 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. Delivered protein 1.0-1.2 g/kg/d.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in RF-CSA ultrasonography	Change in RF-CSA, as measured by ultrasonography at day 7	At day 7 after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of RRT-free days at day 28		At day 28 after randomization
Numbers of MV-free days at day 28		At day 28 after randomization
Change in muscle mass by BIA	measured by bioimpedance analysis at day 7	At day 7 after randomization
ICU length of stay		At day 28 after randomization
Hospital length of stay		At day 28 after randomization
Daily changes in urea levels		From randomization to the end of treatment at 7 days
Incidence of gastrointestinal intolerance		through study completion, an average of 1 month
CPAx		At Randomization and At the end of treatment 7 days

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 0306/69

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No