ICULIP, Influence of Two Lipid Emulsions in the Nosocomial Infection in Critical Patients
- Conditions
- Critical Illness
- Registration Number
- NCT00396461
- Lead Sponsor
- B. Braun Medical SA
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 212
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (22)
Hospital Universitari de Girona Doctor Josep Trueta
🇪🇸Girona, Spain
Hospital Universitario "Puerta del Mar"
🇪🇸Cádiz, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital ClÃnico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Son Dureta
🇪🇸Palma de Mallorca, Baleares, Spain
Hospital Universitari Vall d'Hebrón
🇪🇸Barcelona, Spain
Hospital Universitario Del RÃo Hortega
🇪🇸Valladolid, Spain
Hospital Universitario Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital General Universitario "Reina SofÃa"
🇪🇸Murcia, Spain
Hospital del Mar (Institut Municipal d'Assistència Sanità ria, IMAS)
🇪🇸Barcelona, Spain
Hospital de Cruces
🇪🇸Barakaldo, Bizcaya, Spain
Hospital Universitario de Gran Canaria Dr. NegrÃn
🇪🇸Las Palmas de Gran Canaria, Gran Canaria, Spain
Complejo Hospitalario Materno Insular de Gran Canaria
🇪🇸Las Palmas de Gran Canaria, Gran Canaria, Spain
Hospital Universitario de Bellvitge (H.U.B.)
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Regional Universitario Carlos Haya
🇪🇸Málaga, Spain
Hospital Universitario de Valme
🇪🇸Sevilla, Spain
Hospital Universitario "Virgen de la Arrixaca"
🇪🇸El Palmar, Murcia, Spain
Hospital Severo Ochoa
🇪🇸Leganés, Madrid, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Fundación Jiménez DÃaz
🇪🇸Madrid, Spain