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

NCT07596043 | Not Yet Recruiting

• 1 other identifier: 0306/69
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Kidney Failure Stage 3; Continuous Renal Replacement Therapy (CRRT)

Outcome Measures

Primary Outcomes (1)

• Change in RF-CSA ultrasonography

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

  At day 7 after randomization

Secondary Outcomes (8)

• 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

  At day 7 after randomization

• ICU length of stay

  At day 28 after randomization

• Hospital length of stay

  At day 28 after randomization

Study Arms (2)

High protein group

EXPERIMENTAL

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

Standard protein group

ACTIVE COMPARATOR

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

Interventions

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.

High protein group

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

Standard protein group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

King chula memorial hospital

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Wiphat Kittiweerawong, MD

CONTACT

+66899496165; inter.wiphat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Rectus femoris ultrasonography was performed twice on day 1 and day 7 after randomization by one expert musculoskeletal radiologist blinded to clinical information Both feeds are isocaloric and isovolemic and identical in terms of color, odor and consistency
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)