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https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-000705-86/ES

VALL HEBRON UNIVERSITY HOSPITAL - DAVID BERLANA

dberlana@vhebron.net

2020-05-05

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

Age ≥ 18 years. Patients with at least 5 days of PN. Baseline liver parameters before PN: GGT, alkaline phosphatase < 100 U/dL and direct bilirubin <1.2 mg/dL al inicio de NP. Liver parameter alterations: GGT ≥ 300 U/dL, alkaline phosphatase ≥ 200 U/dL or direct bilirubin ≥1.8 mg/dL Forseeing to receive at least 5 days of PN. Admitted in the ICU of the Valle Hebron University Hospital Willing to give their IC in writing for the trial and be able to do so. Criterios de inclusión: Pacientes ≥ 18 años. Que hayan recibido al menos 5 días de NP. Que hayan presentado valores de GGT, fosfasa alcalina < 100 U/dL y de bilirrubina <1.2 mg/dL al inicio de NP (dentro de las 36h previas o si no hay disponibilidad 24h posteriores). Presenten 2 de los siguientes valores: GGT ≥ 300 U/dL, fosfatasa alcalina ≥ 200 U/dL o valores de bilirrubina ≥1.8 mg/dL Se prevea una continuación de la NP ≥ 5 días. Paciente esté ingresado en la UCI del HUVH Aceptación del paciente (consentimiento informado)

- Lipids administration contraindicated - Have a history of hypersensitivity of idiosincratic reactions to any component of intravenous lipid emulsions. - Home parenteral nutrition patients - Liver transplantation - Liver parameters alterations before PN: 20% above upper normal values. - Patients rejection to participate. Criterios de exclusión Contraindicada la administración de lípidos. Alergia a algún componente presente en la NP. Paciente con NP domiciliaria Trasplante hepático Valores bioquímicos de parámetros hepáticos al inicio de la NP por encima del 20% del límite superior de valores normales Negativa del paciente

3

VALL HEBRON UNIVERSITY HOSPITAL

18

None

Spain

Critical disease at enrollment

8: Critical disease at enrollment

117

Primary end point is the change of liver function parameters: GGT , from the value the day of inclusion to the end of PN. La variable principal es la diferencia en la evolución del parámetro bioquímico hepático GGT, entre el momento de inclusión del paciente y el final de la NP.

Declared number of arm (3.0) differs from found arms (7.0)

Phase 4

[{"arm_notes": "unclear combination of treatment", "treatment_id": 2195, "treatment_name": "Omega 3 fatty acid+parenteral nutrition", "treatment_type": "Vitamins and dietary supplements+nutrition", "pharmacological_treatment": "Pharmacological treatment+non pharmacological treatment"}, {"arm_notes": "unclear combination of treatment", "treatment_id": 2195, "treatment_name": "Omega 3 fatty acid+parenteral nutrition", "treatment_type": "Vitamins and dietary supplements+nutrition", "pharmacological_treatment": "Pharmacological treatment+non pharmacological treatment"}, {"arm_notes": "unclear combination of treatment", "treatment_id": 2194, "treatment_name": "Parenteral nutrition", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}]