On Demand Versus Protocol-guided Renal Replacement Therapy for Management of Stage 3 Acute Kidney Injury in Patients With Cirrhosis
28 de novembro de 2017 atualizado por: Institute of Liver and Biliary Sciences, India
On Demand Versus Protocol-guided Renal Replacement Therapy for Management of Stage 3 Acute Kidney Injury in Patients With Cirrhosis -A Prospective Randomized Controlled Trial
Intervention: All patients at presentation would be assessed for the underlying cause of and will be managed by removal of all precipitants(careful review of medications, diuretics, nephrotoxic drugs,vasodilators or non-steroidal anti-inflammatory drugs). The second step would be to consider plasma volume expansion in patients with hypovolemia (the choice of fluid could either be a crystalloid or albumin or even blood as indicated) along with identification and early treatment of bacterial infections. Along with this patients with a differential diagnosis of HRS-AKI would be given terlipressin ( or noradrenaline/octreotide midodrine in case of contraindication to terlipressin). Patients with a clinical diagnosis of ATN would be randomized to the on-demand versus protocol-guided dialysis groups. Further, patients with urine output of less than 0.5ml/kg/hour for 4-6 hours despite adequate fluid resuscitation and vasoconstrictors would also be subjected to randomization.
- In the on-demand group patients would get dialysis only when patient fulfills absolute criteria requiring dialysis such as metabolic acidosis with ph<7.2, hyperkalemia, refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of less than 0.5ml/kg for more than 24-48 hours from the time of randomization
- In the protocol guided group patients all patients would be considered for dialysis within 6 hours of randomization After randomization patients would receive dialysis as three sessions per week of at least 4 h with a blood flow >200 mL/min and a dialysate flow >500 mL/min in intermittent group and as 20-25 mL/kg/h of effluent, by filtration and/or diffusion in continuous form until recovery of renal functions
Visão geral do estudo
Status
Desconhecido
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Antecipado)
2
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Delhi
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New Delhi, Delhi, Índia, 110070
- Institute of Liver and Biliary Sciences
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Patients with cirrhosis (diagnosed based on clinical, biochemical,radiological or histological diagnosis) with stage 3 Acute Kidney Injury defined as an increase of serum creatinine to more than 300 fold and more than 4 mg/dl.
Exclusion Criteria:
- Patients with age less than 18 years
- Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD Chronic Obstructive Pulmonary Disease)
- Pregnancy
- Chronic kidney disease on hemodialysis
- Patients with post renal obstructive AKI (Acute Kidney Injury), AKI (Acute Kidney Injury) suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
- Patients already meeting emergency criteria for immediate hemodialysis at the time of randomization (serum potassium>6 meq/lt, metabolic acidosis ph<7.12, acute pulmonary edema, severe volume overload with hypoxemia non-responsive to diuretic treatment)
- Patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit
- Extremely moribund patients with an expected life expectancy of less than 24 hours
- Failure to give informed consent from family members.
- Hemodynamic instability requiring very high dose of vasopressors.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Protocol Guided-RRT
In the on-demand group patients would get dialysis only when patient fulfills absolute criteria requiring dialysis such as metabolic acidosis with ph<7.2, hyperkalemia, refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of less than 0.5ml/kg for more than 24-48 hours from the time of randomization.
|
In the on-demand group patients would get dialysis only when patient fulfills absolute criteria requiring dialysis such as metabolic acidosis with ph<7.2, hyperkalemia, refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of less than 0.5ml/kg for more than 24-48 hours from the time of randomization.
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Comparador Ativo: On Demand-RRT
In the protocol guided group patients all patients would be considered for dialysis within 6 hours of randomization After randomization patients would receive dialysis as three sessions per week of at least 4 h with a blood flow >200 mL/min and a dialysate flow >500 mL/min in intermittent group and as 20-25 mL/kg/h of effluent, by filtration and/or diffusion in continuous form until recovery of renal functions
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Patients to be randomized to the intervention as per standard of care
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Recovery of renal functions in both groups
Prazo: day 14
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day 14
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Adverse effects of dialysis in the first session in both groups
Prazo: 48 hours
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48 hours
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Improvement in SOFA (by 2 points) scores in both groups
Prazo: 48 hours
|
48 hours
|
|
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Improvement in MELD ( by 2 points) scores in both groups
Prazo: 48 hours
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48 hours
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Improvement in APACHE ( by 2 points) scores in both groups
Prazo: 48 hours
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48 hours
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Change to End Stage Renal Disease with requirement of maintenance hemodialysis at least twice a week in both groups
Prazo: 4 weeks
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4 weeks
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Improvement in renal functions in both groups
Prazo: 7 days
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7 days
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Mortality in both groups
Prazo: 1 month
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1 month
|
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Mortality in both groups
Prazo: 3 month
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3 month
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Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups.
Prazo: 6 hours
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Response as assessed by either improvement in urine output >0.5ml/kg/hour, acid-base status or renal functions.
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6 hours
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Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups.
Prazo: 12 hours
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Response as assessed by either improvement in urine output >0.5ml/kg/hour, acid-base status or renal functions.
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12 hours
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Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury
Prazo: 24 hours
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Response as assessed by either improvement in urine output >0.5ml/kg/hour, acid-base status or renal functions.
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24 hours
|
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Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups
Prazo: 24 hours
|
Response as assessed by either improvement in urine output >0.5ml/kg/hour, acid-base status or renal functions.
|
24 hours
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
1 de julho de 2018
Conclusão Primária (Antecipado)
1 de julho de 2019
Conclusão do estudo (Antecipado)
1 de julho de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
17 de outubro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de outubro de 2016
Primeira postagem (Estimativa)
19 de outubro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de novembro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de novembro de 2017
Última verificação
1 de novembro de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ILBS-AKI-Cirrhosis
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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