- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Wiphat Kittiweerawong, MD
- Numer telefonu: +66899496165
- E-mail: inter.wiphat@gmail.com
Lokalizacje studiów
-
-
Bangkok
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Bangkok, Bangkok, Tajlandia, 10330
- King chula memorial hospital
-
Kontakt:
- Nuttha Lumlertgul, MD, PhD
-
Kontakt:
- Wiphat Kittiweerawong, MD
- Numer telefonu: 0899496165
- E-mail: inter.wiphat@gmail.com
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Aktywny komparator: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in RF-CSA ultrasonography
Ramy czasowe: At day 7 after randomization
|
Change in RF-CSA, as measured by ultrasonography at day 7
|
At day 7 after randomization
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Numbers of RRT-free days at day 28
Ramy czasowe: At day 28 after randomization
|
At day 28 after randomization
|
|
|
Numbers of MV-free days at day 28
Ramy czasowe: At day 28 after randomization
|
At day 28 after randomization
|
|
|
Change in muscle mass by BIA
Ramy czasowe: At day 7 after randomization
|
measured by bioimpedance analysis at day 7
|
At day 7 after randomization
|
|
ICU length of stay
Ramy czasowe: At day 28 after randomization
|
At day 28 after randomization
|
|
|
Hospital length of stay
Ramy czasowe: At day 28 after randomization
|
At day 28 after randomization
|
|
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Daily changes in urea levels
Ramy czasowe: From randomization to the end of treatment at 7 days
|
From randomization to the end of treatment at 7 days
|
|
|
Incidence of gastrointestinal intolerance
Ramy czasowe: through study completion, an average of 1 month
|
through study completion, an average of 1 month
|
|
|
CPAx
Ramy czasowe: At Randomization and At the end of treatment 7 days
|
At Randomization and At the end of treatment 7 days
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 0306/69
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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