King chula memorial hospital
Bangkok, 10330, Thailand
NCT Number: NCT07596043
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
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Bangkok, 10330, Thailand
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: At day 7 after randomization
Change in RF-CSA, as measured by ultrasonography at day 7
Time frame: At day 28 after randomization
Time frame: At day 28 after randomization
Time frame: At day 7 after randomization
measured by bioimpedance analysis at day 7
Time frame: At day 28 after randomization
Time frame: At day 28 after randomization
Time frame: From randomization to the end of treatment at 7 days
Time frame: through study completion, an average of 1 month
Time frame: At Randomization and At the end of treatment 7 days
Contact information is provided by the study sponsor or research team.
Chulalongkorn University
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT06254703
Acute Kidney Failure Stage 3, Acute Kidney Injury
Bangkok, Thailand
View Trial DetailsNCT04622384
Acute Kidney Failure Stage 3, Acute Kidney Injury
Aarhus, Denmark
View Trial DetailsNCT07518303
Acute Kidney Injury, Continuous Renal Replacement Therapy (CRRT)
View Trial DetailsNCT07365111
Acute Kidney Injury, Continuous Renal Replacement Therapy (CRRT)
Edmonton, Alberta, Canada
View Trial Details