Early enteral supply of Intestamin® in severe sepsis and its influence on organ dysfunction

ISRCTN	ISRCTN27438588
DOI	https://doi.org/10.1186/ISRCTN27438588
Protocol serial number	N-IS1-10-UK
Sponsor	Fresenius Kabi Deutschland GmbH (Germany)
Funder	Fresenius Kabi GmbH (Germany)

Submission date: 01/12/2005
Registration date: 02/06/2006
Last edited: 23/02/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Richard Beale
Scientific

Adult Intensive Care Unit
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised, prospective, double-blind, placebo-controlled, monocentric, isoenergetic
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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)
Ethics approval(s)	St Thomas' Hospital Research Ethics Committee
Health condition(s) or problem(s) studied	Sepsis
Intervention	Intestamin® versus placebo
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Intestamin
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	52
Key inclusion criteria	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
Key exclusion criteria	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, Kaposis 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
Date of first enrolment	01/01/2006
Date of final enrolment	01/01/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Adult Intensive Care Unit

London
SE1 7EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2008		Yes	No