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ISRCTN
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ISRCTN27438588
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ClinicalTrials.gov identifier
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Public title
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Early enteral supply of Intestamin® in severe sepsis and its influence on organ dysfunction
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Scientific title
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Acronym
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N/A
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Serial number at source
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N-IS1-10-UK
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Study hypothesis
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To confirm that early enteral supply of Intestamin® to critically ill, septic patients results in a significantly faster reduction of daily total Sequential Organ Failure Assessment (SOFA) scores (organ dysfunction) during the first 5 treatment days compared to placebo (control supplement)
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Lay summary
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Ethics approval
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St Thomas' Hospital Research Ethics Committee
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Study design
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Randomised, prospective, double-blind, placebo-controlled, monocentric, isoenergetic
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Sepsis
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Participants - inclusion criteria
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Major entry criteria (suspected or proven infection, presence of a systemic response to the infection within the 48-hour period immediately preceding enrolment into the study, have or have had one or more sepsis-induced organ failures within the 48-hour period immediately preceding enrolment into the study).
1. Age ≥18 years
2. Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥10
3. Precipitating injury (surgery, trauma, hypovolemia, episode of infection or sepsis) occurred within the last 48 hours before intensive care unit (ICU) entry
4. Expected length of stay (LOS) in the ICU >3 days
5. Indication for enteral nutrition for 5-10 days
6. Start of nutritional therapy with Intestamin or control supplement within 24 hours after inclusion criteria are fulfilled
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Participants - exclusion criteria
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1. Age <18 , for both sexes
2. Body weight <50 kg or >130 kg (estimated)
3. Pregnant and lactating women, women of child-bearing age. Pregnancy in women of child-bearing age should be ruled out with a pregnancy test.
4. Gastrointestinal obstructions, high output enterocutaneous fistulae
5. Severe diarrhoea unresponsive to codeine or loperamide
6. Biopsy proven cirrhosis and documented portal hypertension; episodes of past upper gastrointestinal bleeding attributed to portal hypertension; prior episodes of hepatic failure, encephalopathy or coma
7. Human immunodeficiency virus (HIV)-positive patients with an aquired immune deficiency syndrome (AIDS)-defining process, such as Pneumocystis carnii pneumonia, Kaposi’s sarcoma, progressive multifocal leukoncephalopathy (PML), Mycobacterium avium disease, Epstein-Barr virus (EBV) infection, or lymphoma, or a known CD4 count <200 cells/µl
8. Simultaneous participation in another clinical study
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Anticipated start date
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01/01/2006
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Anticipated end date
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01/01/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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52
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Interventions
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Intestamin® versus placebo
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Primary outcome measure(s)
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Organ dysfunction assessed by daily total SOFA score and by the delta daily total SOFA score (significant reduction).
Variables for organ dysfunction (worst parameter per day):
1. Pulmonary: pO2/FiO2
2. Cardiovascular: hypotension
3. Renal: creatinine
4. Hepatic: bilirubin
5. Coagulation: thrombocytes
6. Central nervous system (CNS): Glasgow coma score
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Secondary outcome measure(s)
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1. Mortality (28-day, ICU and hospital, six-months)
2. Infectious complications (e.g. pneumonia, wound infection, abscesses)
3. APACHE II
4. Organ failure-free days
5. LOS in ICU
6. LOS in hospital (intervention until discharge)
7. Duration of antibiotic treatment (antibiotics days)
8. Duration of ventilation (ventilator days)
9. Duration of renal support
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Sources of funding
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Fresenius Kabi GmbH (Germany)
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18007263
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Contact name
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Dr
Richard
Beale
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Address
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Adult Intensive Care Unit
St Thomas' Hospital
Lambeth Palace Road
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City/town
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London
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Zip/Postcode
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SE1 7EH
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Country
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United Kingdom
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Sponsor
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Fresenius Kabi Deutschland GmbH (Germany)
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Address
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Kabi Strategic Business Center
Clinical Affairs
Enteral Nutrition
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City/town
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Bad Homburg
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Zip/Postcode
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D-61352
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Country
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Germany
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Date applied
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01/12/2005
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Last edited
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23/02/2010
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Date ISRCTN assigned
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02/06/2006
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