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
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Wiphat Kittiweerawong, MD
- Número de telefone: +66899496165
- E-mail: inter.wiphat@gmail.com
Locais de estudo
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Bangkok
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Bangkok, Bangkok, Tailândia, 10330
- King chula memorial hospital
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Contato:
- Nuttha Lumlertgul, MD, PhD
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Contato:
- Wiphat Kittiweerawong, MD
- Número de telefone: 0899496165
- E-mail: inter.wiphat@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
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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.
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|
Comparador Ativo: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in RF-CSA ultrasonography
Prazo: At day 7 after randomization
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Change in RF-CSA, as measured by ultrasonography at day 7
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At day 7 after randomization
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Numbers of RRT-free days at day 28
Prazo: At day 28 after randomization
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At day 28 after randomization
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Numbers of MV-free days at day 28
Prazo: At day 28 after randomization
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At day 28 after randomization
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Change in muscle mass by BIA
Prazo: At day 7 after randomization
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measured by bioimpedance analysis at day 7
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At day 7 after randomization
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ICU length of stay
Prazo: At day 28 after randomization
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At day 28 after randomization
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Hospital length of stay
Prazo: At day 28 after randomization
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At day 28 after randomization
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Daily changes in urea levels
Prazo: From randomization to the end of treatment at 7 days
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From randomization to the end of treatment at 7 days
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Incidence of gastrointestinal intolerance
Prazo: through study completion, an average of 1 month
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through study completion, an average of 1 month
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CPAx
Prazo: At Randomization and At the end of treatment 7 days
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At Randomization and At the end of treatment 7 days
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 0306/69
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