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ICULIP, Influence of Two Lipid Emulsions in the Nosocomial Infection in Critical Patients (ICULIP)

This study has been terminated.
ClinicalTrials.gov Identifier:
First Posted: November 7, 2006
Last Update Posted: July 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
B. Braun Medical SA
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
Critical Illness Drug: MCT/LCT (1:1) Drug: MCT/LCT/omega-3 (5:4:1) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.

Further study details as provided by B. Braun Medical SA:

Primary Outcome Measures:
  • The analyses will particularly focus on: Pneumonia associated with mechanical ventilation, Catheter infection, Bacteraemia not associated with catheter, Urinary infection, Infection of surgical wounds and Intra-abdominal abscess and peritonitis. [ Time Frame: Patients will receive at least 5 days of PN. Clinical condition and nosocomial infection will be monitored daily until the first phase of the study is completed on day 28 or the patient is discharged from the unit. ]
  • Compare the incidence of nosocomial infection associated with the administration of two different lipid solutions in total parenteral nutrition of patients in an Intensive Care Unit. [ Time Frame: Patients will receive at least 5 days of PN. Clinical condition and nosocomial infection will be monitored daily until the first phase of the study is completed on day 28 or the patient is discharged from the unit. ]

Secondary Outcome Measures:
  • Study mortality at the end of the study and 6 months after discharge from ICU; Hospital stay and/or in Intensive Care Unit; Mechanical ventilation days; Assessment of hepatic function; Assessment of nutritional efficacy. [ Time Frame: At the end of the study and 6 months after discharge from ICU. ]

Estimated Enrollment: 212
Study Start Date: November 2006
Study Completion Date: February 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TPN A (Group I)
Emulsion based on 20% MCT/LCT (50:50 ratio)
Drug: MCT/LCT (1:1)
Emulsion based on 20% MCT/LCT (50:50 ratio)
Experimental: TPN B (Group II)
Emulsion based on 20% MCT/LCT/w3 (50:40:10 ratio), medium- and long-chain triglycerides and fish oil triglycerides
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.
Other Name: LIPOPLUS

  Show Detailed Description


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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:

  • Severe malnutrition
  • Major intra-abdominal surgery
  • Peritonitis
  • Intestinal ischaemia
  • Intestinal occlusion
  • Gastrointestinal fistulas
  • Small intestine

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:

  • 75% of the calculated energy requirements have not been reached after three days receiving enteral nutrition.
  • Gastrointestinal complications have been suffered as a result of enteral nutrition that cannot be treated or are persistent in the first 3 days of admission.

In this case EN will be suspended and the patient will be included in the protocol receiving PN.


  • APACHE II < 13
  • Morbid obesity (BMI ≥ 39)
  • Hepatic disease defined within the following set of parameters:

    1. Portal hypertension with gastrointestinal bleeding on admission
    2. Clinically apparent hepatocellular ascites
    3. Hepatocellular bilirubin higher than 3 mg/dL
    4. Serum albumin less than 30 g/L with portal hypertension
    5. Grade II or higher encephalopathy
    6. Clinical diagnosis of alcoholic hepatitis
  • Chronic renal insufficiency defined by one of the following criteria:

    1. Plasmatic creatinine greater than 4 mg/dL
    2. Chronic peritoneal dialysis or haemodialysis
  • Patients with severe acquired or familial hyperlipidaemias (> 400 mg/day) of any kind
  • Serious chronic neurological disease defined by one of the following criteria:

    1. Cerebrovascular accident with persistent neurological deficit in the past six months
    2. Neurological deficit that necessitates chronic confinement
  • Neoplastic patients with metastasis and a life expectancy of less than six months
  • Patients that underwent chemotherapy or radiotherapy during the month prior to the study
  • Patients that received chronic treatment with corticoids in the month preceding admission to ICU. Patients receiving treatment with corticoids since admission to ICU for septic shock should not be excluded.
  • Continuous infusion treatment for more than 24 hours with propofol or with other pharmaceuticals where lipid emulsions are used as the vehicle
  • Infectious diseases transmitted through the blood, products derived from blood or urine: hepatitis B, C and HIV
  • Inclusion in another clinical trial
  • Having received TPN in the month prior to inclusion in the study
  • Pregnancy
  • Refusal to participate in the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396461

Hospital Son Dureta
Palma de Mallorca, Baleares, Spain, 07014
Hospital Universitario de Bellvitge (H.U.B.)
Hospitalet de Llobregat, Barcelona, Spain, 08097
Hospital de Cruces
Barakaldo, Bizcaya, Spain, 48903
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Gran Canaria, Spain, 35010
Complejo Hospitalario Materno Insular de Gran Canaria
Las Palmas de Gran Canaria, Gran Canaria, Spain, 35016
Hospital Severo Ochoa
Leganés, Madrid, Spain, 28911
Hospital Universitario "Virgen de la Arrixaca"
El Palmar, Murcia, Spain, 30120
Hospital General Universitario de Alicante
Alicante, Spain, 03010
Hospital del Mar (Institut Municipal d'Assistència Sanitària, IMAS)
Barcelona, Spain, 08003
Hospital Universitari Vall d'Hebrón
Barcelona, Spain, 08035
Hospital Universitario "Puerta del Mar"
Cádiz, Spain, 11009
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Spain, 17007
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
Hospital Universitario Arnau de Vilanova
Lleida, Spain, 25198
Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital General Universitario "Reina Sofía"
Murcia, Spain, 30003
Hospital Regional Universitario Carlos Haya
Málaga, Spain, 29010
Hospital Universitario de Valme
Sevilla, Spain, 41014
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Hospital Universitario Del Río Hortega
Valladolid, Spain, 47010
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
B. Braun Medical SA
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)
  More Information

Additional Information:
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García-de-Lorenzo A. Lipid emulsions with different phospholipid/triglyceride ratio in critically ill septic and traumatic patients. Crit Care Med. 1998 Dec;26(12):2094-5.
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Mathru M, Dries DJ, Zecca A, Fareed J, Rooney MW, Rao TL. Effect of fast vs slow intralipid infusion on gas exchange, pulmonary hemodynamics, and prostaglandin metabolism. Chest. 1991 Feb;99(2):426-9.
Gogos CA, Kalfarentzos F. Total parenteral nutrition and immune system activity: a review. Nutrition. 1995 Jul-Aug;11(4):339-44. Review.
Calder PC, Sherrington EJ, Askanazi J, Newsholme EA. Inhibition of lymphocyte proliferation in vitro by two lipid emulsions with different fatty acid compositions. Clin Nutr. 1994 Apr;13(2):69-74.
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Suchner U, Senftleben U. Immune modulation by polyunsaturated fatty acids during nutritional therapy: interactions with synthesis and effects of eicosanoids. Infusionsther Transfusionsmed. 1994 Jun;21(3):167-82. Review.
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Gadek JE, DeMichele SJ, Karlstad MD, Pacht ER, Donahoe M, Albertson TE, Van Hoozen C, Wennberg AK, Nelson JL, Noursalehi M. Effect of enteral feeding with eicosapentaenoic acid, gamma-linolenic acid, and antioxidants in patients with acute respiratory distress syndrome. Enteral Nutrition in ARDS Study Group. Crit Care Med. 1999 Aug;27(8):1409-20.
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Responsible Party: B. Braun Medical SA
ClinicalTrials.gov Identifier: NCT00396461     History of Changes
Other Study ID Numbers: HC-G-H-0510
2005-003542-33 ( EudraCT Number )
First Submitted: November 3, 2006
First Posted: November 7, 2006
Last Update Posted: July 19, 2013
Last Verified: July 2013

Keywords provided by B. Braun Medical SA:
Critical Illness
Fat Emulsions, Intravenous
Parenteral Nutrition

Additional relevant MeSH terms:
Critical Illness
Cross Infection
Disease Attributes
Pathologic Processes
Iatrogenic Disease

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