ICULIP, Influence of Two Lipid Emulsions in the Nosocomial Infection in Critical Patients - Full Text View

Sponsor:	B. Braun Medical SA
Information provided by (Responsible Party):	B. Braun Medical SA
ClinicalTrials.gov Identifier:	NCT00396461

Purpose

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

Drug Information available for: Lipids

U.S. FDA Resources

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. ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: Yes ]

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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	212
Study Start Date:	November 2006
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (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) Other Name: LIPOFUNDINA
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

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

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.

EXCLUSION CRITERIA:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396461

Locations

Spain
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

Investigators

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:

Spanish Society for Parenteral and Enteral Nutrition This link exits the ClinicalTrials.gov site

ASPEN, American Society for Parenteral and Enteral Nutrition --> Nutrition-related Links This link exits the ClinicalTrials.gov site

Spanish Society for Intensive Medicine, Critical and Coronary Units This link exits the ClinicalTrials.gov site

Publications:

Cerra FB. Hypermetabolism, organ failure, and metabolic support. Surgery. 1987 Jan;101(1):1-14. Review.

Garcia-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. No abstract available.

Bach AC, Frey A, Lutz O. Clinical and experimental effects of medium-chain-triglyceride-based fat Emulsions-A review. Clin Nutr. 1989 Oct;8(5):223-35.

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.

Clarke PJ, Ball MJ, Hands LJ, Dennison AR, Tunbridge A, White K, Kettlewell MG. Use of a lipid containing medium chain triglycerides in patients receiving TPN: a randomized prospective trial. Br J Surg. 1987 Aug;74(8):701-4.

Barton RG. Nutrition support in critical illness. Nutr Clin Pract. 1994 Aug;9(4):127-39. Review.

Suchner U, Katz DP, Furst P, Beck K, Felbinger TW, Senftleben U, Thiel M, Goetz AE, Peter K. Effects of intravenous fat emulsions on lung function in patients with acute respiratory distress syndrome or sepsis. Crit Care Med. 2001 Aug;29(8):1569-74.

Gogos CA, Kalfarentzos FE, Zoumbos NC. Effect of different types of total parenteral nutrition on T-lymphocyte subpopulations and NK cells. Am J Clin Nutr. 1990 Jan;51(1):119-22.

Jensen GL, Mascioli EA, Seidner DL, Istfan NW, Domnitch AM, Selleck K, Babayan VK, Blackburn GL, Bistrian BR. Parenteral infusion of long- and medium-chain triglycerides and reticuloendothelial system function in man. JPEN J Parenter Enteral Nutr. 1990 Sep-Oct;14(5):467-71.

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.

Calder PC. Long-chain n-3 fatty acids and inflammation: potential application in surgical and trauma patients. Braz J Med Biol Res. 2003 Apr;36(4):433-46. Epub 2003 Apr 8. Review.

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.

Weiss G, Meyer F, Matthies B, Pross M, Koenig W, Lippert H. Immunomodulation by perioperative administration of n-3 fatty acids. Br J Nutr. 2002 Jan;87 Suppl 1:S89-94.

Koller M, Senkal M, Kemen M, Konig W, Zumtobel V, Muhr G. Impact of omega-3 fatty acid enriched TPN on leukotriene synthesis by leukocytes after major surgery. Clin Nutr. 2003 Feb;22(1):59-64.

Tsekos E, Reuter C, Stehle P, Boeden G. Perioperative administration of parenteral fish oil supplements in a routine clinical setting improves patient outcome after major abdominal surgery. Clin Nutr. 2004 Jun;23(3):325-30. Erratum in: Clin Nutr. 2004 Aug;23(4):755-6.

Carpentier YA, Van Gossum A, Dubois D, Deckeibaum R. Lipid Metabolism in Parenteral Nutrition. In: Wilmore DW, Carpentier YA (Eds). Metabolic Support of the Critically III Patient. Berlin, Springer-Veriag 1993, pp 35-74

Driscoll DF, Adolph M, Bistrian BR. Lipid emulsions in parenteral nutrition. In: Rombeau JL, Rolandelli R, eds. Parenteral nutrition. Philadelphia: W. B. Saunders Company; 2000:35-39.

Santoli D, Zurier RB. Prostaglandin E precursor fatty acids inhibit human IL-2 production by a prostaglandin E-independent mechanism. J Immunol. 1989 Aug 15;143(4):1303-9. Erratum in: J Immunol 1990 Jan 15;144(2):774.

Kinsella JE, Lokesh B. Dietary lipids, eicosanoids, and the immune system. Crit Care Med. 1990 Feb;18(2 Suppl):S94-113. Review. No abstract available.

Kumar SG, Das UN, Kumar KV, Madhavi N, Das NP, Tan BKH. Effect of n-6 and n-3 fatty acids on the proliferation of human lymphocyes and their secretion of TN F-alpha and IL-2 in vitro. Nutr Res 1992; 12: 815-823.

Grau T, Ruiz de Adana JC, Zubillaga S, Fuerte S, Giron C. [Randomized study of two different fat emulsions in total parenteral nutrition of malnourished surgical patients;effect of infectious morbidity and mortality] Nutr Hosp. 2003 May-Jun;18(3):159-66. Spanish.

Grimminger F, Seeger W, Mayer K. Use of n-3 fatty acid-containing lipid emulsions in the intensive care unit environment: the clinician's view. Clinical Nutrition 2002, 21, Supplement 2: 23-29.

Wichmann MW, Morlion B, Czarnetzki H-D, Thul P, Jauch K-W. Reduction of length of postoperative stay by fish oil containing lipid emulsion - data from a multicenter trial. Clinical Nutrition 2004, 23: 1471

Responsible Party:	B. Braun Medical SA
ClinicalTrials.gov Identifier:	NCT00396461 History of Changes
Other Study ID Numbers:	HC-G-H-0510, 2005-003542-33
Study First Received:	November 3, 2006
Last Updated:	August 31, 2011
Health Authority:	Spain: Spanish Agency of Medicines; Spain: Ministry of Health and Consumption

Keywords provided by B. Braun Medical SA:

Critical Illness
Fat Emulsions, Intravenous
Superinfection
Parenteral Nutrition

Additional relevant MeSH terms:

Critical Illness
Cross Infection
Disease Attributes
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on February 09, 2012