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

NCT00396461 | Terminated Phase 4

• 2 other identifiers: HC-G-H-05102005-003542-33
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

Critical Illness

Keywords

Critical Illness; Fat Emulsions, Intravenous; Superinfection; Parenteral Nutrition

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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 Outcomes (1)

• 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.

  At the end of the study and 6 months after discharge from ICU.

Study Arms (2)

TPN A (Group I)

ACTIVE COMPARATOR

Emulsion based on 20% MCT/LCT (50:50 ratio)

Drug: MCT/LCT (1:1)

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

Drug: MCT/LCT/omega-3 (5:4:1)

Interventions

MCT/LCT (1:1) DRUG

Emulsion based on 20% MCT/LCT (50:50 ratio)

Also known as: LIPOFUNDINA

TPN A (Group I)

MCT/LCT/omega-3 (5:4:1) DRUG

Emulsion based on 20% MCT/LCT/w3 (50:40:10 ratio), medium- and long-chain triglycerides and fish oil triglycerides.

Also known as: LIPOPLUS

TPN B (Group II)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• % 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.

You may not qualify if:

• APACHE II \< 13
• Morbid obesity (BMI ≥ 39)
• Hepatic disease defined within the following set of parameters:
• Portal hypertension with gastrointestinal bleeding on admission
• Clinically apparent hepatocellular ascites
• Hepatocellular bilirubin higher than 3 mg/dL
• Serum albumin less than 30 g/L with portal hypertension
• Grade II or higher encephalopathy
• Clinical diagnosis of alcoholic hepatitis
• Chronic renal insufficiency defined by one of the following criteria:
• Plasmatic creatinine greater than 4 mg/dL
• 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:
• Cerebrovascular accident with persistent neurological deficit in the past six months

Sponsors & Collaborators

• B. Braun Medical SA: lead

Study Sites (22)

Hospital General Universitario de Alicante

Alicante, Alicante, 03010, Spain

Location

Hospital Son Dureta

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Hospital del Mar (Institut Municipal d'Assistència Sanitària, IMAS)

Barcelona, Barcelona, 08003, Spain

Location

Hospital Universitari Vall d'Hebrón

Barcelona, Barcelona, 08035, Spain

Location

Hospital Universitario de Bellvitge (H.U.B.)

L'Hospitalet de Llobregat, Barcelona, 08097, Spain

Location

Hospital de Cruces

Barakaldo, Bizcaya, 48903, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario "Puerta del Mar"

Cadiz, Cádiz, 11009, Spain

Location

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Girona, 17007, Spain

Location

Hospital Universitario de Gran Canaria Dr. Negrín

Las Palmas de Gran Canaria, Gran Canaria, 35010, Spain

Location

Complejo Hospitalario Materno Insular de Gran Canaria

Las Palmas de Gran Canaria, Gran Canaria, 35016, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Granada, 18014, Spain

Location

Hospital Universitario Arnau de Vilanova

Lleida, Lleida, 25198, Spain

Location

Hospital Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario "Virgen de la Arrixaca"

El Palmar, Murcia, 30120, Spain

Location

Hospital General Universitario "Reina Sofía"

Murcia, Murcia, 30003, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, Málaga, 29010, Spain

Location

Hospital Universitario de Valme

Seville, Sevilla, 41014, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital Universitario Del Río Hortega

Valladolid, Valladolid, 47010, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

Location

Related Publications (26)

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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. doi: 10.1097/00003246-199908000-00001.

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• ASPEN Board of Directors: Guidelines for the use of parenteral and enteral nutrition in adults and pediatric patients. JPEN 2001

  BACKGROUND

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• 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.

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• 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.

  BACKGROUND

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  BACKGROUND

Related Links

• Spanish Society for Parenteral and Enteral Nutrition
• ASPEN, American Society for Parenteral and Enteral Nutrition --\> Nutrition-related Links
• Spanish Society for Intensive Medicine, Critical and Coronary Units

MeSH Terms

Conditions

Critical Illness; Superinfection; Hyperphagia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Opportunistic Infections; Infections; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Abelardo García de Lorenzo, MD

  Hospital Universitario La Paz

  STUDY CHAIR

• Alfonso Bonet Saris, MD_Study Coordinator

  University Hospital of Girona Dr. Josep Trueta

  PRINCIPAL INVESTIGATOR

• Teodoro Grau Carmona, MD_Study Coordinator

  Hospital Severo Ochoa Leganés (Madrid)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2006
• First Posted: November 7, 2006
• Study Start: November 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: February 1, 2011
• Last Updated: July 19, 2013

Record last verified: 2013-07

Locations

ES (22)