Condition category
Infections and Infestations
Date applied
01/12/2005
Date assigned
02/06/2006
Last edited
23/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Beale

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N-IS1-10-UK

Study information

Scientific title

Acronym

Study hypothesis

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

St Thomas' Hospital Research Ethics Committee

Study design

Randomised, prospective, double-blind, placebo-controlled, monocentric, isoenergetic

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Sepsis

Intervention

Intestamin® versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Intestamin

Primary outcome measures

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 trial start date

01/01/2006

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

52

Participant 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, 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

Recruitment start date

01/01/2006

Recruitment end date

01/01/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Adult Intensive Care Unit
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Fresenius Kabi Deutschland GmbH (Germany)

Sponsor details

Kabi Strategic Business Center
Clinical Affairs
Enteral Nutrition
Bad Homburg
D-61352
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Fresenius Kabi GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18007263

Publication citations

  1. Results

    Beale RJ, Sherry T, Lei K, Campbell-Stephen L, McCook J, Smith J, Venetz W, Alteheld B, Stehle P, Schneider H, Early enteral supplementation with key pharmaconutrients improves Sequential Organ Failure Assessment score in critically ill patients with sepsis: outcome of a randomized, controlled, double-blind trial., Crit. Care Med., 2008, 36, 1, 131-144, doi: 10.1097/01.CCM.0000297954.45251.A9.

Additional files

Editorial Notes