On Demand Versus Protocol-guided Renal Replacement Therapy for Management of Stage 3 Acute Kidney Injury in Patients With Cirrhosis
28 de noviembre de 2017 actualizado 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
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
2
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Delhi
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New Delhi, Delhi, India, 110070
- Institute of liver and Biliary Sciences
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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 activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Recovery of renal functions in both groups
Periodo de tiempo: day 14
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day 14
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adverse effects of dialysis in the first session in both groups
Periodo de tiempo: 48 hours
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48 hours
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Improvement in SOFA (by 2 points) scores in both groups
Periodo de tiempo: 48 hours
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48 hours
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Improvement in MELD ( by 2 points) scores in both groups
Periodo de tiempo: 48 hours
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48 hours
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Improvement in APACHE ( by 2 points) scores in both groups
Periodo de tiempo: 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
Periodo de tiempo: 4 weeks
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4 weeks
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Improvement in renal functions in both groups
Periodo de tiempo: 7 days
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7 days
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Mortality in both groups
Periodo de tiempo: 1 month
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1 month
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Mortality in both groups
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 24 hours
|
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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de julio de 2018
Finalización primaria (Anticipado)
1 de julio de 2019
Finalización del estudio (Anticipado)
1 de julio de 2019
Fechas de registro del estudio
Enviado por primera vez
17 de octubre de 2016
Primero enviado que cumplió con los criterios de control de calidad
17 de octubre de 2016
Publicado por primera vez (Estimar)
19 de octubre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de noviembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
28 de noviembre de 2017
Última verificación
1 de noviembre de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ILBS-AKI-Cirrhosis
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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