Critical IllnessPhase 4ICULIPNCT00396461
ICULIP, Influence of Two Lipid Emulsions in the Nosocomial Infection in Critical Patients
A Phase 4 study testing MCT/LCT (1:1) and MCT/LCT/omega-3 (5:4:1) in people with Critical Illness, run by B. Braun Medical SA at 22 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- MCT/LCT (1:1) and MCT/LCT/omega-3 (5:4:1)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 22 sitesSpain
- Study dates
- Nov 2006to Feb 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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.
- Having received TPN in the month prior to inclusion in the study
- Pregnancy
- Refusal to participate in the study
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Spain22 sites
Hospital General Universitario de Alicante
Alicante, Alicante, 03010
Hospital de Cruces
Barakaldo, Bizcaya, 48903
Hospital del Mar (Institut Municipal d'Assistència Sanitària, IMAS)
Barcelona, Barcelona, 08003
Hospital Universitari Vall d'Hebrón
Barcelona, Barcelona, 08035
Hospital Universitario "Puerta del Mar"
Cadiz, Cádiz, 11009
Hospital Universitario "Virgen de la Arrixaca"
El Palmar, Murcia, 30120
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Girona, 17007
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014
Hospital Universitario de Bellvitge (H.U.B.)
L'Hospitalet de Llobregat, Barcelona, 08097
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Gran Canaria, 35010
Complejo Hospitalario Materno Insular de Gran Canaria
Las Palmas de Gran Canaria, Gran Canaria, 35016
Hospital Severo Ochoa
Leganés, Madrid, 28911
Hospital Universitario Arnau de Vilanova
Lleida, Lleida, 25198
Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital Regional Universitario Carlos Haya
Málaga, Málaga, 29010
Hospital General Universitario "Reina Sofía"
Murcia, Murcia, 30003
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, 07014
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario de Valme
Seville, Sevilla, 41014
Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010
Hospital Universitario Del Río Hortega
Valladolid, Valladolid, 47010
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, 50009
About this study
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.
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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- MCT/LCT (1:1), MCT/LCT/omega-3 (5:4:1)
- Keywords
- Critical Illness, Fat Emulsions, Intravenous, Superinfection, Parenteral Nutrition
- Medical subject headings
- Critical Illness, Superinfection, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCT/LCT (1:1)Drug
Also called LIPOFUNDINA
Emulsion based on 20% MCT/LCT (50:50 ratio)
MCT/LCT/omega-3 (5:4:1)Drug
Also called LIPOPLUS
Emulsion based on 20% MCT/LCT/w3 (50:40:10 ratio), medium- and long-chain triglycerides and fish oil triglycerides.
| Study group | Role | What they receive |
|---|---|---|
| TPN A (Group I) | Active comparator | Emulsion based on 20% MCT/LCT (50:50 ratio) Receives: 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 Receives: Drug: MCT/LCT/omega-3 (5:4:1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At the end of the study and 6 months after discharge from ICU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B. Braun Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abelardo García de Lorenzo, MD, Study chair, Hospital Universitario La PazAlfonso Bonet Saris, MD_Study Coordinator, Principal investigator, University Hospital of Girona Dr. Josep TruetaTeodoro Grau Carmona, MD_Study Coordinator, Study chair, Hospital Severo Ochoa Leganés (Madrid)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396461
- Sponsor's protocol ID
- HC-G-H-0510
- Other IDs
- 2005-003542-33, 2005
- Acronym
- ICULIP
- Status last verified
- Jul 2013
- First submitted
- 3 Nov 2006
- Last updated
- 19 Jul 2013
- Results posted
- No
Publications
Cerra FB. Hypermetabolism, organ failure, and metabolic support. Surgery. 1987 Jan;101(1):1-14.
PubMed 3541266Garcia-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. doi: 10.1097/00003246-199812000-00049. No abstract available.
PubMed 9875927Bach 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. doi: 10.1016/0261-5614(89)90032-0.
PubMed 16837294Mathru 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. doi: 10.1378/chest.99.2.426.
PubMed 1989806Gogos CA, Kalfarentzos F. Total parenteral nutrition and immune system activity: a review. Nutrition. 1995 Jul-Aug;11(4):339-44.
PubMed 8580573Calder 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. doi: 10.1016/0261-5614(94)90062-0.
PubMed 16843362Clarke 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. doi: 10.1002/bjs.1800740818.
PubMed 3115354Barton RG. Nutrition support in critical illness. Nutr Clin Pract. 1994 Aug;9(4):127-39. doi: 10.1177/0115426594009004127.
PubMed 8078451Suchner 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. doi: 10.1097/00003246-200108000-00012.
PubMed 11505129Gogos 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. doi: 10.1093/ajcn/51.1.119.
PubMed 2136970Jensen 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. doi: 10.1177/0148607190014005467.
PubMed 2122019Suchner 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. doi: 10.1159/000222968.
PubMed 7919904Calder 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. doi: 10.1590/s0100-879x2003000400004. Epub 2003 Apr 8.
PubMed 12700820Gadek 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.
PubMed 10470743Weiss 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. doi: 10.1079/bjn2001461.
PubMed 11895158
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00396461
- Acronym / sponsor ID
- ICULIP / HC-G-H-0510
- Conditions
- Critical Illness
- Keywords
- Critical Illness, Fat Emulsions, Intravenous, Superinfection, Parenteral Nutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- B. Braun Medical SAIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 7 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPN A (Group I) | Active comparator | Drug: MCT/LCT (1:1)Emulsion based on 20% MCT/LCT (50:50 ratio) |
| TPN B (Group II) | Experimental | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (21 listed)
- APACHE II < 13
- Morbid obesity (BMI ≥ 39)
- Hepatic disease defined within the following set of parameters:
- Chronic renal insufficiency defined by one of the following criteria:
- Patients with severe acquired or familial hyperlipidaemias (> 400 mg/day) of any kind
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCT/LCT (1:1)Also: LIPOFUNDINAEmulsion based on 20% MCT/LCT (50:50 ratio) | Drug | TPN A (Group I) |
| MCT/LCT/omega-3 (5:4:1)Also: LIPOPLUSEmulsion based on 20% MCT/LCT/w3 (50:40:10 ratio), medium- and long-chain triglycerides and fish oil triglycerides. | Drug | TPN B (Group II) |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
- Background: PubMed 3541266Cerra FB. Hypermetabolism, organ failure, and metabolic support. Surgery. 1987 Jan;101(1):1-14.
- Background: PubMed 9875927Garcia-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. doi: 10.1097/00003246-199812000-00049. No abstract available.
- Background: PubMed 16837294Bach 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. doi: 10.1016/0261-5614(89)90032-0.
- Background: PubMed 1989806Mathru 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. doi: 10.1378/chest.99.2.426.
- Background: PubMed 8580573Gogos CA, Kalfarentzos F. Total parenteral nutrition and immune system activity: a review. Nutrition. 1995 Jul-Aug;11(4):339-44.
- Background: PubMed 16843362Calder 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. doi: 10.1016/0261-5614(94)90062-0.
- Background: PubMed 3115354Clarke 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. doi: 10.1002/bjs.1800740818.
- Background: PubMed 8078451Barton RG. Nutrition support in critical illness. Nutr Clin Pract. 1994 Aug;9(4):127-39. doi: 10.1177/0115426594009004127.
- Background: PubMed 11505129Suchner 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. doi: 10.1097/00003246-200108000-00012.
- Background: PubMed 2136970Gogos 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. doi: 10.1093/ajcn/51.1.119.
- Background: PubMed 2122019Jensen 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. doi: 10.1177/0148607190014005467.
- Background: PubMed 7919904Suchner 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. doi: 10.1159/000222968.
- Spanish Society for Parenteral and Enteral NutritionLink provided by the sponsor.
- ASPEN, American Society for Parenteral and Enteral Nutrition --\> Nutrition-related LinksLink provided by the sponsor.
- Spanish Society for Intensive Medicine, Critical and Coronary UnitsLink provided by the sponsor.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abelardo García de Lorenzo, MD study chair
Hospital Universitario La Paz
Alfonso Bonet Saris, MD_Study Coordinator principal investigator
University Hospital of Girona Dr. Josep Trueta
Teodoro Grau Carmona, MD_Study Coordinator study chair
Hospital Severo Ochoa Leganés (Madrid)
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MCT/LCT (1:1) and MCT/LCT/omega-3 (5:4:1) in people with Critical Illness, run by B. Braun Medical SA at 22 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00396461, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2013.