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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wiphat Kittiweerawong, MD | Contact | +66899496165 | inter.wiphat@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King chula memorial hospital | Bangkok | Bangkok | 10330 | Thailand |
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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
| 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 |
|
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 |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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