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

Primary Purpose

Critical Illness

Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
MCT/LCT (1:1)
MCT/LCT/omega-3 (5:4:1)
Sponsored by
B. Braun Medical SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Critical Illness, Fat Emulsions, Intravenous, Superinfection, Parenteral Nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Son Dureta
  • Hospital Universitario de Bellvitge (H.U.B.)
  • Hospital de Cruces
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Universitario de Gran Canaria Dr. Negrín
  • Complejo Hospitalario Materno Insular de Gran Canaria
  • Hospital Severo Ochoa
  • Hospital Universitario "Virgen de la Arrixaca"
  • Hospital General Universitario de Alicante
  • Hospital del Mar (Institut Municipal d'Assistència Sanitària, IMAS)
  • Hospital Universitari Vall d'Hebrón
  • Hospital Universitario "Puerta del Mar"
  • Hospital Universitari de Girona Doctor Josep Trueta
  • Hospital Universitario Virgen de las Nieves
  • Hospital Universitario Arnau de Vilanova
  • Fundación Jiménez Díaz
  • Hospital General Universitario "Reina Sofía"
  • Hospital Regional Universitario Carlos Haya
  • Hospital Universitario de Valme
  • Hospital Clínico Universitario de Valencia
  • Hospital Universitario Del Río Hortega
  • Hospital Universitario Miguel Servet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TPN A (Group I)

TPN B (Group II)

Arm Description

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

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

Outcomes

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.
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.

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.

Full Information

First Posted
November 3, 2006
Last Updated
July 18, 2013
Sponsor
B. Braun Medical SA
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1. Study Identification

Unique Protocol Identification Number
NCT00396461
Brief Title
ICULIP, Influence of Two Lipid Emulsions in the Nosocomial Infection in Critical Patients
Acronym
ICULIP
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Study Start Date
November 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B. Braun Medical SA

4. Oversight

5. Study Description

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.
Detailed Description
During the last years the most widely used lipid emulsion for parenteral nutrition has been based on soybean oil. This first generation of lipid emulsions used in TPN contained w-6 series polyunsaturated long-chain fatty acids (LCT) from soy, maize, sunflower and safflower oil. LCT contain an excess of linoleic acid which, when metabolised, produce large quantities of arachidonic acid and its metabolites. Although the generally used doses seem safe (1-2 g/kg/day by continuous perfusion), alterations in pulmonary function in patients with acute adult respiratory distress syndrome have been described, as have alterations in platelet function, hepatic function and haemodynamics, which are attributed to the excess of said metabolites. However, the most important side effect of the LCT lipid infusions is its influence on the immune response. Experimental and clinical studies show that LCT can interfere with various stages of the immune response such as the production of antibodies, complement synthesis, granulocytic and lymphocytic activity and the reticuloendothelial system. Various hypotheses have been formulated to explain the modulator effect of the polyunsaturated fatty acids on immune function: changes in the permeability of the cellular membrane, modifications in the synthesis of eicosanoids and the presence of peroxides derived from the oxidation of polyunsaturated fatty acids. In summary, although linoleic acid as a dietary essential fatty acid is important, its excessive intake is associated with undesirable immunological and inflammatory events. Thus it is recommended that soybean oil should be partly replaced by other lipids. To avoid these side effects the second generation lipid emulsions were developed. These contain a combination of medium- and long-chain fatty acids (MCT/LCT) with lower w-6 fatty acid content. MCT/LCT lipid emulsions are safe and do not produce biochemical or metabolic alterations or gaseous exchange in patients with ARDS. MCT/LCT combinations seem to reduce the generation of eicosanoids and do not alter the immune response in in-vitro and experimental studies. The impact of these differences on the nosocomial infection and the clinical prognosis of the patients has not been studied sufficiently despite the fact that some studies show reduced mortality and morbidity using MCT/LCT emulsions when compared with the use of pure LCT emulsions. MCT/LCT emulsions are normally used in clinical practice on patients that have required parenteral nutrition for 20 years. Recently, the clinical use in artificial nutrition of omega-3 series polyunsaturated fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) present in many fish oils has been significant. EPA is a precursor to certain eicosanoid series that compensate the proinflammatory effects of the eicosanoids in arachidonic acid (omega-6 series). The objective is immunomodulation to attenuate the inflammatory response of patients without negatively impacting on the immune function. The use of enteral diets enriched with omega-3 series fatty acids (fish oil) in post-operation cancer patients showed a reduction in the number of days in hospital and infectious complications. The use of fish oil or fat emulsions enriched with fish oil (omega-3) in parenteral nutrition has already been the subject of various studies: where modulation of the inflammatory response markers has been shown, reduces the stay in hospital and the need for mechanical ventilation in patients undergoing major abdominal surgery, reduces the stay in hospital in patients undergoing digestive surgery… So, w-3 lipids exhibit strong immunologic properties. They offer the possibility to counterbalance the negative effects of conventional w-6 fatty acids. Recent studies exhibit positive effects of intravenous use of fish oil on immunologic functions and clinical parameters in surgical and septic patients The purpose of this study is 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) (w3:w6 is 1:7) and the other will comprise an MCT/LCT/fish oil emulsion (50:40:10 ratio) (w3:w6 is 1:2,7). The secondary objective of this study is to analyse mortality in hospital and up to 6 months after discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Critical Illness, Fat Emulsions, Intravenous, Superinfection, Parenteral Nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
212 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TPN A (Group I)
Arm Type
Active Comparator
Arm Description
Emulsion based on 20% MCT/LCT (50:50 ratio)
Arm Title
TPN B (Group II)
Arm Type
Experimental
Arm Description
Emulsion based on 20% MCT/LCT/w3 (50:40:10 ratio), medium- and long-chain triglycerides and fish oil triglycerides
Intervention Type
Drug
Intervention Name(s)
MCT/LCT (1:1)
Other Intervention Name(s)
LIPOFUNDINA
Intervention Description
Emulsion based on 20% MCT/LCT (50:50 ratio)
Intervention Type
Drug
Intervention Name(s)
MCT/LCT/omega-3 (5:4:1)
Other Intervention Name(s)
LIPOPLUS
Intervention Description
Emulsion based on 20% MCT/LCT/w3 (50:40:10 ratio), medium- and long-chain triglycerides and fish oil triglycerides.
Primary Outcome Measure Information:
Title
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.
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abelardo García de Lorenzo, MD
Organizational Affiliation
Hospital Universitario La Paz
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alfonso Bonet Saris, MD_Study Coordinator
Organizational Affiliation
Hospital Universitari de Girona Doctor Josep Trueta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Teodoro Grau Carmona, MD_Study Coordinator
Organizational Affiliation
Hospital Severo Ochoa Leganés (Madrid)
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Son Dureta
City
Palma de Mallorca
State/Province
Baleares
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital Universitario de Bellvitge (H.U.B.)
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08097
Country
Spain
Facility Name
Hospital de Cruces
City
Barakaldo
State/Province
Bizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario de Gran Canaria Dr. Negrín
City
Las Palmas de Gran Canaria
State/Province
Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Facility Name
Complejo Hospitalario Materno Insular de Gran Canaria
City
Las Palmas de Gran Canaria
State/Province
Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Hospital Severo Ochoa
City
Leganés
State/Province
Madrid
ZIP/Postal Code
28911
Country
Spain
Facility Name
Hospital Universitario "Virgen de la Arrixaca"
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital del Mar (Institut Municipal d'Assistència Sanitària, IMAS)
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario "Puerta del Mar"
City
Cádiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital Universitari de Girona Doctor Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Universitario Arnau de Vilanova
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital General Universitario "Reina Sofía"
City
Murcia
ZIP/Postal Code
30003
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario Del Río Hortega
City
Valladolid
ZIP/Postal Code
47010
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

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Links:
URL
http://www.senpe.com
Description
Spanish Society for Parenteral and Enteral Nutrition
URL
http://www.nutritioncare.org/
Description
ASPEN, American Society for Parenteral and Enteral Nutrition --> Nutrition-related Links
URL
http://www.semicyuc.org/
Description
Spanish Society for Intensive Medicine, Critical and Coronary Units

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

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