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Sponsored by: |
B. Braun Medical SA |
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Information provided by: | B. Braun Medical SA |
ClinicalTrials.gov Identifier: | NCT00396461 |
This study aims to analyse the effect of two total parenteral nutrition diets with lipid emulsions of different compositions on the incidence of nosocomial infection in critical patients. One diet will contain an MCT/LCT emulsion concentrated to 20% (50:50 ratio) and the other will comprise an MCT/LCT/fish oil emulsion (50:40:10 ratio). The secondary objective of this study is to analyse mortality in hospital and up to 6 months of discharge.
Condition | Intervention | Phase |
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Critical Illness |
Drug: MCT/LCT (1:1) Drug: MCT/LCT/omega-3 (5:4:1) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Phase IV-IV. ICULIP,a Prospective,Multi-Centre,Randomised,Comparative,Double-Blind Study to Evaluate Two Different Types of Lipid Emulsions Used for Total Parenteral Nutrition in Critical Patients and Their Influence on Nosocomial Infection. |
Estimated Enrollment: | 212 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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TPN A (Group I): Active Comparator
Emulsion based on 20% MCT/LCT (50:50 ratio)
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Drug: MCT/LCT (1:1)
Emulsion based on 20% MCT/LCT (50:50 ratio)
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TPN B (Group II): Experimental
Emulsion based on 20% MCT/LCT/w3 (50:40:10 ratio), medium- and long-chain triglycerides and fish oil triglycerides
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Drug: MCT/LCT/omega-3 (5:4:1)
Emulsion based on 20% MCT/LCT/w3 (50:40:10 ratio), medium- and long-chain triglycerides and fish oil triglycerides.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Patients of both sexes, prospective admission to Intensive Care Units (ICUs), over 18 years, where TPN is required as a nutritional metabolic support for a minimum period of 5 days and where said patients have signed the informed consent form.
The indications for administration of parenteral nutrition shall be those recommended by the American Society of Parenteral and Enteral Nutrition (ASPEN), and in particular:
Patients of both sexes, over 18 years, that commencing nutritional support with enteral diets in the first 3 days of admission to ICU require parenteral nutrition as:
In this case EN will be suspended and the patient will be included in the protocol receiving PN.
EXCLUSION CRITERIA:
Hepatic disease defined within the following set of parameters:
Chronic renal insufficiency defined by one of the following criteria:
Serious chronic neurological disease defined by one of the following criteria:
Contact: Jaume Jané Pujol, Product & Study Manager | +34-93.586.64.18 | jaume.jane_pujol@bbraun.com |
Contact: Carlos Requena, Group Marketing Manager | +34-93.586.62.96 | carlos.requena@bbraun.com |
Spain | |
Hospital General Universitario de Alicante | Recruiting |
Alicante, Spain, 03010 | |
Contact: José Acosta Escribano, MD +34-965.93.83.00 acosta_jos@telefonica.net | |
Principal Investigator: José Acosta Ecribano, MD | |
Hospital del Mar (Institut Municipal d'Assistència Sanitària, IMAS) | Recruiting |
Barcelona, Spain, 08003 | |
Contact: Inmaculada Albert, MD +34-93.248.30.14 ialbert@imas.imim.es | |
Principal Investigator: Inmaculada Albert, MD | |
Hospital Universitari Vall d'Hebrón | Recruiting |
Barcelona, Spain, 08035 | |
Contact: Mercè Planas, MD +34-93.274.62.62 mplanas@vhebron.net | |
Principal Investigator: Mercè Planas, MD | |
Hospital Universitario "Puerta del Mar" | Recruiting |
Cádiz, Spain, 11009 | |
Contact: Lucas Picazo Soto, MD +34-956.00.21.00 lpicazo@telefonica.net | |
Principal Investigator: Lucas Picazo Soto, MD | |
Hospital Regional Universitario Carlos Haya | Recruiting |
Málaga, Spain, 29010 | |
Contact: Francisco Fernández Ortega, MD +34-95.239.05.00 patferon@eresmas.com | |
Principal Investigator: Francisco Fernández Ortega, MD | |
Hospital Universitario Virgen de las Nieves | Recruiting |
Granada, Spain, 18014 | |
Contact: José Castaño Pérez, MD +34-958.02.00.00 antonioj.perez.sspa@juntadeandalucia.es | |
Principal Investigator: José Castaño Pérez, MD | |
Fundación Jiménez Díaz | Not yet recruiting |
Madrid, Spain, 28040 | |
Contact: Paloma González, MD +34-91.550.49.67 pgonzalez@fjd.es | |
Principal Investigator: Paloma González, MD | |
Hospital General Universitario "Reina Sofía" | Recruiting |
Murcia, Spain, 30003 | |
Contact: Carmen Sánchez, MD +34-968.35.90.00 carmen.sanchez6@carm.es | |
Principal Investigator: Carmen Sánchez, MD | |
Hospital Universitari de Girona Doctor Josep Trueta | Recruiting |
Girona, Spain, 17007 | |
Contact: Alfons Bonet Saris, MD_Study Coordinator +34-972.940.200 uci.abonet@htrueta.scs.es | |
Principal Investigator: Alfons Bonet Saris, MD_Study Coordinator | |
Hospital Universitario de Valme | Recruiting |
Sevilla, Spain, 41014 | |
Contact: José A. Irles, MD +34-95.501.50.00 josea.irles.sspa@juntadeandalucia.es | |
Principal Investigator: José A. Irles, MD | |
Hospital Clínico Universitario de Valencia | Recruiting |
Valencia, Spain, 46010 | |
Contact: Alfonso Mesejo, MD +34-963.86.26.00 mesejo_alf@gva.es | |
Principal Investigator: Alfonso Mesejo, MD | |
Hospital Universitario Del Río Hortega | Not yet recruiting |
Valladolid, Spain, 47010 | |
Contact: Luis A. Dominguez, MD +34-983.42.04.00 ldominguez@hurh.sacyl.es | |
Principal Investigator: Luis A. Dominguez, MD | |
Spain, Baleares | |
Hospital Son Dureta | Not yet recruiting |
Palma de Mallorca, Baleares, Spain, 07014 | |
Contact: Pedro Marsé, MD +34-971.17.50.00 pmarse@telefonica.net | |
Principal Investigator: Pedro Marsé, MD | |
Spain, Barcelona | |
Hospital Universitario de Bellvitge (H.U.B.) | Recruiting |
Hospitalet de Llobregat, Barcelona, Spain, 08097 | |
Contact: José I. Herrero Meseguer, MD +34-93.260.75.11 jiherrero@csub.scs.es | |
Principal Investigator: José I. Herrero Meseguer, MD | |
Spain, Cantabria | |
Hospital Universitario Marqués de Valdecilla | Recruiting |
Santander, Cantabria, Spain, 39008 | |
Contact: Javier Ordóñez González, MD +34-942.20.25.20 javier.ordonez@telefonica.net | |
Principal Investigator: Javier Ordóñez González, MD | |
Spain, Gran Canaria | |
Hospital Universitario de Gran Canaria Dr. Negrín | Recruiting |
Las Palmas de Gran Canaria, Gran Canaria, Spain, 35010 | |
Contact: Sergio Ruiz Santana, MD +34-928.45.06.73 sruisan@gobiernodecanarias.org | |
Principal Investigator: Sergio Ruiz Santana, MD | |
Complejo Hospitalario Materno Insular de Gran Canaria | Recruiting |
Las Palmas de Gran Canaria, Gran Canaria, Spain, 35016 | |
Contact: Manuel Sánchez Palacios, MD +34-928.44.13.92 msanpal@gobiernodecanarias.org | |
Principal Investigator: Manuel Sánchez Palacios, MD | |
Spain, Madrid | |
Hospital Severo Ochoa | Recruiting |
Leganés, Madrid, Spain, 28911 | |
Contact: Jorge López Martínez, MD +34-91.481.80.00 jlopezm.hsvo@salud.madrid.org | |
Principal Investigator: Jorge López Martínez, MD | |
Spain, Murcia | |
Hospital Universitario "Virgen de la Arrixaca" | Recruiting |
El Palmar, Murcia, Spain, 30120 | |
Contact: Rafael Nuñez Ruiz, MD +34-968.36.95.00 rafanr@telefonica.net | |
Principal Investigator: Rafael Nuñez Ruiz, MD |
Study Chair: | Abelardo García de Lorenzo, MD | Hospital Universitario La Paz (Madrid) |
Principal Investigator: | Alfonso Bonet Saris, MD_Study Coordinator | Hospital Universitari de Girona Doctor Josep Trueta |
Study Chair: | Teodoro Grau Carmona, MD_Study Coordinator | Hospital Severo Ochoa Leganés (Madrid) |
Responsible Party: | B. Braun Melsungen AG ( B. Braun Medical SA ) |
Study ID Numbers: | HC-G-H-0510, Eudra-CT: 2005-003542-33 |
Study First Received: | November 3, 2006 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00396461 |
Health Authority: | Spain: Spanish Agency of Medicines; Spain: Ministry of Health and Consumption |
Critical Illness Fat Emulsions, Intravenous Superinfection Parenteral Nutrition |
Critical Illness Cross Infection |
Disease Attributes Pathologic Processes Infection |