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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05119361
Early Dry Cohort : Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit. (Early Dry)
Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit. A Before-after Study.
Fluid overload is frequent and associated with mortality in critically ill patients, especially those with acute kidney injury. If fluid loading is a cornerstone of a resuscitation strategy, some authors promote an evacuation phase to limit the fluid overload exposure (deresuscitation strategy). In patients with continuous renal therapy, often presenting an inadequate diuresis, it includes the net ultrafiltration setting. A potential side effect of deresuscitation strategy is to induce iatrogenic hypovolemia.
We have implemented a perfusion-based protocol to induce systematic early fluid removal on patients after haemodynamic stabilization. We would like to observe the impact on the fluid balance of such a protocol and to explore the recruitment capacity of our centre and exploratory outcomes to lead a future randomized control study.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Bron, Francia
- Hôpital cardiologique Louis Pradel - HCL
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- - Age ≥ 18 ans
- Acute kidney injury with continuous renal replacement therapy
- Fluid overload > 5%
- Equivalent Norepinephrine dose < 0,5 µg/kg/min
Exclusion Criteria:
- - Chronic intermittent haemodialysis
- Active bleeding
- Stroke with coma
- Pregnancy
- advanced directives to withhold or withdraw life-sustaining treatment
- patient's opposition to the use of his/her personal health data."
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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before protocol implementation
A control group reflecting usual practice about net ultrafiltration and deresuscitation strategy in patients with continuous renal replacement therapy in our Department. All patients meeting eligibility criteria between 01/01/2020 and 31/12/2021 will be include. |
After meeting eligibility criteria, patients have a net ultrafiltration of 2mL/kg/h with systematic perfusion monitoring (lactate concentration, central venous saturation, mottling score and capillary refill time) and restrictive input. If the patient presents hypoperfusion (at least to sign), net ultrafiltration is stopped and haemodynamic optimized. If the patient presents pulmonary oedema or right ventricular failure, with venous congestion, ultrafiltration is set at 3mL/kg/h. Ultrafiltration is set between 0.5 and 1mL/kg/h when the following criteria are fulfilled: weight inferior to the admission weight; central venous pressure inferior to 5mmHg; absence of clinical oedema. The haemodynamic status is reevaluated all six hours. |
after protocol implementation
All patients treated by our deresuscitation protocol between 15/02/2020 and 15/08/2021 will be included.
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After meeting eligibility criteria, patients have a net ultrafiltration of 2mL/kg/h with systematic perfusion monitoring (lactate concentration, central venous saturation, mottling score and capillary refill time) and restrictive input. If the patient presents hypoperfusion (at least to sign), net ultrafiltration is stopped and haemodynamic optimized. If the patient presents pulmonary oedema or right ventricular failure, with venous congestion, ultrafiltration is set at 3mL/kg/h. Ultrafiltration is set between 0.5 and 1mL/kg/h when the following criteria are fulfilled: weight inferior to the admission weight; central venous pressure inferior to 5mmHg; absence of clinical oedema. The haemodynamic status is reevaluated all six hours. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Computed cumulative fluid balance (mL) at day 5 after protocol onset.
Periodo de tiempo: Day 5 after protocol onset.
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Cumulative between input and output, defined as follow:
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Day 5 after protocol onset.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 454
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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