Early enteral supply of Intestamin® in severe sepsis and its influence on organ dysfunction
| ISRCTN | ISRCTN27438588 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27438588 |
| Secondary identifying numbers | N-IS1-10-UK |
- 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
Scientific
Adult Intensive Care Unit
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
Study information
| Study design | Randomised, prospective, double-blind, placebo-controlled, monocentric, isoenergetic |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Intestamin |
| Primary outcome measure | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2006 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Adult Intensive Care Unit
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Fresenius Kabi Deutschland GmbH (Germany)
Industry
Industry
Kabi Strategic Business Center
Clinical Affairs
Enteral Nutrition
Bad Homburg
D-61352
Germany
"ROR" |
https://ror.org/01v376g59 |
|---|
Funders
Funder type
Industry
Fresenius Kabi GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
