- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07596043
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
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Wiphat Kittiweerawong, MD
- Telefonní číslo: +66899496165
- E-mail: inter.wiphat@gmail.com
Studijní místa
-
-
Bangkok
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Bangkok, Bangkok, Thajsko, 10330
- King chula memorial hospital
-
Kontakt:
- Nuttha Lumlertgul, MD, PhD
-
Kontakt:
- Wiphat Kittiweerawong, MD
- Telefonní číslo: 0899496165
- E-mail: inter.wiphat@gmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
|
|
Aktivní komparátor: 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.
|
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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in RF-CSA ultrasonography
Časové okno: At day 7 after randomization
|
Change in RF-CSA, as measured by ultrasonography at day 7
|
At day 7 after randomization
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Numbers of RRT-free days at day 28
Časové okno: At day 28 after randomization
|
At day 28 after randomization
|
|
|
Numbers of MV-free days at day 28
Časové okno: At day 28 after randomization
|
At day 28 after randomization
|
|
|
Change in muscle mass by BIA
Časové okno: At day 7 after randomization
|
measured by bioimpedance analysis at day 7
|
At day 7 after randomization
|
|
ICU length of stay
Časové okno: At day 28 after randomization
|
At day 28 after randomization
|
|
|
Hospital length of stay
Časové okno: At day 28 after randomization
|
At day 28 after randomization
|
|
|
Daily changes in urea levels
Časové okno: From randomization to the end of treatment at 7 days
|
From randomization to the end of treatment at 7 days
|
|
|
Incidence of gastrointestinal intolerance
Časové okno: through study completion, an average of 1 month
|
through study completion, an average of 1 month
|
|
|
CPAx
Časové okno: At Randomization and At the end of treatment 7 days
|
At Randomization and At the end of treatment 7 days
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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