Acute Kidney Failure Stage 3PROTEIN-CRRTNCT07596043
Effect of High Versus Standard Protein Intake in Critically Ill Patients With Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
A study testing High protein group and Standard protein group in people with Acute Kidney Failure Stage 3 and Continuous Renal Replacement Therapy (CRRT), run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure Stage 3, Continuous Renal Replacement Therapy (CRRT)
- What is being tested?
- High protein group and Standard protein group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteThailand
- Study dates
- 27 Sep 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nuttha Lumlertgul, MD, PhD contact
Thailand1 site, 1 recruiting
- Recruiting
King chula memorial hospital
Bangkok, Bangkok, 10330
Wiphat Kittiweerawong, MD, 0899496165, inter.wiphat@gmail.com
Nuttha Lumlertgul, MD, PhD
About this study
Official 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)
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.
Read more
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
- Being tested
- High protein group, Standard protein group
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein groupOther
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 groupOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard protein group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in RF-CSA ultrasonography
Change in RF-CSA, as measured by ultrasonography at day 7
Measured: At day 7 after randomization
Secondary outcomes (8)
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
Measured: At day 28 after randomization
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.
Measured: At day 28 after randomization
Change in muscle mass by BIA
measured by bioimpedance analysis at day 7
Measured: At day 7 after randomization
ICU length of stay
the total number of days a patient spends in ICU
Measured: At day 28 after randomization
Hospital length of stay
The total number of days a patient spends in hospital from their admission date to their discharge date
Measured: At day 28 after randomization
Daily changes in urea levels
Trend serum urea nitrogen (SUN) in mg/dL in 7 days after randomization
Measured: From randomization to the end of treatment at 7 days
Incidence of gastrointestinal intolerance
Gastrointestinal intolerance is defined as gastrointestinal events reported by primary physicians or patients within treatment period as follows: Vomiting, Diarrhea, Abdominal distension.
Measured: through study completion, an average of 1 month
CPAx
Chelsea Critical Care Physical Assessment (CPAx) 10-item bedside assessment designed to measure physical function and recovery in critically ill ICU patients
Measured: At Randomization and At the end of treatment 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start27 Sep 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Failure Stage 3Studies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuttha Lumlertgul, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596043
- Sponsor's protocol ID
- 0306/69
- Acronym
- PROTEIN-CRRT
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07596043
- Acronym / sponsor ID
- PROTEIN-CRRT / 0306/69
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 27 Sep 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High protein group | Experimental | Other: High protein groupPatients 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. |
| Standard protein group | Active comparator | Other: Standard protein groupPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High protein groupPatients 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. | Other | High protein group |
| Standard protein groupPatients 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 | Other | Standard protein group |
Primary outcome
Change in RF-CSA ultrasonography
Time frame: At day 7 after randomization
Change in RF-CSA, as measured by ultrasonography at day 7
8 secondary outcomes
Numbers of RRT-free days at day 28
Time frame: At day 28 after randomization
Numbers of MV-free days at day 28
Time frame: At day 28 after randomization
Change in muscle mass by BIA
Time frame: At day 7 after randomization
ICU length of stay
Time frame: At day 28 after randomization
Hospital length of stay
Time frame: At day 28 after randomization
Daily changes in urea levels
Time frame: From randomization to the end of treatment at 7 days
Incidence of gastrointestinal intolerance
Time frame: through study completion, an average of 1 month
CPAx
Time frame: At Randomization and At the end of treatment 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nuttha Lumlertgul, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High protein group and Standard protein group in people with Acute Kidney Failure Stage 3 and Continuous Renal Replacement Therapy (CRRT), run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wiphat Kittiweerawong, MD (+66899496165, inter.wiphat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in RF-CSA ultrasonography (time frame: At day 7 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.