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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02678325
The Basel Enteral High Protein Study
Tolerance of Early High Protein Nutrition of the Critically Ill: Comparison of a Protein-rich Enteral Formula With a Standardized High Carbohydrate Product on Total Calorie and Protein Intake
The objective of this study is to compare the difference in daily protein intake of critically ill patients in two standardized enteral nutrition formulas (20% versus 33% percent) with the same caloric density of 1.2 kcal/ml.
The total amount of protein taken in on day four after starting the early enteral feeding is defined as primary endpoint.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
For years, the Surgical Intensive Care Unit of the University Hospital Basel has used an early enteral approach for the feeding of critically ill patients with different formulas that have high protein content (20% of total energy). However, the energy goal in the first week is only 20 kcal for normal-weight and 12.5 kcal for obese patients, which results in daily protein amounts of 0.8 to 1 g/kg bodyweight (BW), so that additional protein has to be administered. Due to a suggestion of the dietetic service of the University Hospital Basel, Fresenius Kabi produced a whey based enteral feeding formula for intensive care patients. Specific further adaptations for this patient group included micronutrients and a fatty acid profile as well as low fibres. Surgical Intensive Care Unit of the University Hospital Basel now are offered the opportunity to test this formula in clinical practice and hypothesize that this specific high-protein (30% of energy) enteral formula reaches the same amount of daily caloric intake with a higher total daily amount of protein and equal intestinal tolerance compared to a usual intestinal nutritional formula.
In order to test this hypothesis, investigators plan a double-blind, randomized and controlled study with the aim to achieve a target protein quantity of ≥1.3 g/kg BW with an energy target of 20kcal/kg BW per day, based on a new, specifically designed formula for critically ill patients. The amount of protein on day four after starting the early enteral feeding is defined as primary endpoint. Secondary endpoints are the total amount of calories, the nitrogen balance on day five as well as side effects like gastric residual content, diarrhoea and constipation. Inclusion criteria were an expected stay at the ICU of four days or longer on admission and 18 years of age or older Exclusion criteria consisted of BMI ≤ 18, pregnancy, intestinal perforation, mechanical intestinal obstruction, terminal state of consuming disease, severely impaired liver function and noradrenaline ≥0.5µg/kg BW/min.. On this purpose, 90 critically ill patients will get either of the two enteral feeding products as described above. In case of the event that an increased protein intake can be obtained by the protein-rich formula, an additional study will investigate the influence of early protein-rich nutrition on skeletal muscle wasting with critically ill patients.
In a pre-study investigators will administer the high protein formula to 20 patients to test tolerance and suitability for the nutritional Targets in question. Tolerance will be defined by the absence of one of the following clinical symptoms :
- Reflux
- Diarrhoea
- Constipation
- Nausea
- Vomiting
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Basel, Suiza, 4031
- University Hospital Basel
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adult patients (age 18 years or older)
- expected stay at the ICU of four days upon admittance or longer
- expected enteral feeding during at least four days.
Exclusion Criteria:
- BMI ≤ 18
- Mechanical intestinal obstruction
- Intestinal perforation
- Severely impaired liver function
- Terminal state of consuming disease
- Noradrenaline ≥0.5µg/kg BW/min
- Pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Standardized normal protein enteral nutrition formula
Standardized enteral nutrition formula with a caloric density of 1.2 kcal/ml and protein percentage 20% of the total caloric intake
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double-blind randomized controlled clinical trial of critically ill patients to explore values of high enteral protein administration (compared to normal enteral protein administration) on muscle breakdown and mortality.
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Experimental: Standardized high protein enteral nutrition formula
Standardized enteral nutrition formula with a caloric density of 1.2 kcal/ml and protein percentage 33% of the total caloric intake
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A double-blind randomized controlled clinical trial of critically ill patients to explore values of high enteral protein administration on muscle breakdown and mortality.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The amount of protein
Periodo de tiempo: 4 days
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The amount of protein administered on day four after starting the early enteral feeding.
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4 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The total amount of calories
Periodo de tiempo: 4 days
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Indirect Calorimetry
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4 days
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The nitrogen balance on day four
Periodo de tiempo: 4 days
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Nitrogen input - nitrogen loss measured over 4 days
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4 days
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Gastric residual Content in ml
Periodo de tiempo: 4 days
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ml
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4 days
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Number of diarrhea events
Periodo de tiempo: 4 days
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Number
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4 days
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occurence of constipation as measured in time without defecation
Periodo de tiempo: 4 days
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time frame without defecation
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4 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Martin Siegemund, Prof. Dr. MD, Deputy Chief Physician, Surgical Intensive Care Unit, University Hospital Basel
Publicaciones y enlaces útiles
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 (Estimar)
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
Otros números de identificación del estudio
- 2016-00041
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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Ensayos clínicos sobre Standardized normal protein enteral nutrition
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Zhu WeimingReclutamiento
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