Critical IllnessIntestaminNCT01167075
A Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)
A study testing Fresubin Original and Intestamin plus Fresubin Original in people with Critical Illness and Adult, run by Hannover Medical School at 1 site in Germany.
Trial summary
The aim of the study is to assess the efficacy and tolerability of the low-volume supplement. The investigators randomized critically ill patients to receive Intestamin plus Fresubin or Fresubin alone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Critical Illness, Adult, Sepsis
- What is being tested?
- Fresubin Original and Intestamin plus Fresubin Original
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2006to Feb 2009
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sepsis or SIRS (APACHE score 10-30),
- no severe gastrointestinal tract or metabolic diseases,
- enteral feeding within 48 h of admission,
- age 18-75 years,
- written consent by patient or next of kin. -
Who cannot join
- participation in a drug trial within the last 4 weeks before inclusion in this study,
- previous participation in this study,
- expected patient survival of less than 6 days,
- pregnancy or lactation,
- patients with unstable vital signs that would probably cause incidents that would make participation impossible or would lead to discontinuation,
- severe liver disease with cytolysis (ASAT >10 N) or impaired detoxification (ammonia >50 mmol/L, bilirubin > 50 μmol/L),
Show all 11Show fewer
- gastrointestinal surgery in the last 4 weeks,
- severe enteritis/colitis,
- short intestine syndrome,
- gastrointestinal bleeding that requires intervention,
- patients who could not be enterally fed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Prospective, Controlled, Double-blind, Single-center Pilot Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)
The aim of the study is to assess the efficacy and tolerability of the low-volume supplement. The investigators randomized critically ill patients to receive Intestamin plus Fresubin or Fresubin alone.
Read the detailed description
To compare early supplementation with antioxidants and glutamine using an enteral pharmaconutrition supplement (Intestamin®) to an energy adjusted standard elementary diet and to investigate its affect on clinical efficacy and tolerability in critically ill patients with sepsis/SIRS.
Methods: This was a prospective controlled randomized study in 58 critically ill patients. They received either Intestamin or a diluted Fresubin solution. After 10 or 14 days inflammatory parameters, catecholamine need, and maximal enteral delivery were determined.
- Being tested
- Fresubin Original, Intestamin plus Fresubin Original
- Keywords
- critically ill, sepsis, antioxidants, enteral nutrition, SIRS (APACHE score 10-30), enteral feeding within 48 h of admission
- Medical subject headings
- Critical Illness, Sepsis, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresubin OriginalDietary supplement
Intestamin plus Fresubin OriginalDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Fresubin Original | Active comparator | Not described Receives: Dietary Supplement: Fresubin Original |
| Intestamin plus Fresubin Original | Experimental | Not described Receives: Dietary Supplement: Intestamin plus Fresubin Original |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in ICU
The primary endpoints were length of stay in ICU and sufficient enteral feed.
Measured: 14 days
Secondary outcomes (1)
mortality
Secondary endpoints were APACHE score, days of fever, artificial ventilation, and antibiotics, mortality, catecholamine need, inflammation parameters (CRP, leukocytes, etc.), pneumonia with detection of bacteria, need for insulin, and length of hospital stay.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startFeb 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167075
- Sponsor's protocol ID
- 3941
- Acronym
- Intestamin
- Status last verified
- Dec 2005
- First submitted
- 21 Jul 2010
- Last updated
- 22 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Schneider A, Markowski A, Momma M, Seipt C, Luettig B, Hadem J, Wilhelmi M, Manns MP, Wedemeyer J. Tolerability and efficacy of a low-volume enteral supplement containing key nutrients in the critically ill. Clin Nutr. 2011 Oct;30(5):599-603. doi: 10.1016/j.clnu.2011.04.003. Epub 2011 May 31.
PubMed 21621886
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Controlled, Double-blind, Single-center Pilot Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)
- ClinicalTrials.gov ID
- NCT01167075
- Acronym / sponsor ID
- Intestamin / 3941
- Keywords
- critically ill, sepsis, antioxidants, enteral nutrition, SIRS (APACHE score 10-30), enteral feeding within 48 h of admission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Fresenius Kabi
- Study start
- Feb 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 22 Jul 2010 (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.
The aim of the study is to assess the efficacy and tolerability of the low-volume supplement. The investigators randomized critically ill patients to receive Intestamin plus Fresubin or Fresubin alone.
Detailed description
To compare early supplementation with antioxidants and glutamine using an enteral pharmaconutrition supplement (Intestamin®) to an energy adjusted standard elementary diet and to investigate its affect on clinical efficacy and tolerability in critically ill patients with sepsis/SIRS.
Methods: This was a prospective controlled randomized study in 58 critically ill patients. They received either Intestamin or a diluted Fresubin solution. After 10 or 14 days inflammatory parameters, catecholamine need, and maximal enteral delivery were determined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresubin Original | Active comparator | Dietary Supplement: Fresubin Original |
| Intestamin plus Fresubin Original | Experimental | Dietary Supplement: Intestamin plus Fresubin Original |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- sepsis or SIRS (APACHE score 10-30),
- no severe gastrointestinal tract or metabolic diseases,
- enteral feeding within 48 h of admission,
- age 18-75 years,
- written consent by patient or next of kin. -
Key exclusion criteria (11 listed)
- participation in a drug trial within the last 4 weeks before inclusion in this study,
- previous participation in this study,
- expected patient survival of less than 6 days,
- pregnancy or lactation,
- patients with unstable vital signs that would probably cause incidents that would make participation impossible or would lead to discontinuation,
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 |
|---|---|---|
| Fresubin Original | Dietary supplement | Fresubin Original |
| Intestamin plus Fresubin Original | Dietary supplement | Intestamin plus Fresubin Original |
Primary outcome
Length of stay in ICU
Time frame: 14 days
The primary endpoints were length of stay in ICU and sufficient enteral feed.
1 secondary outcome
mortality
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2010.
- Derived from this study: PubMed 21621886Schneider A, Markowski A, Momma M, Seipt C, Luettig B, Hadem J, Wilhelmi M, Manns MP, Wedemeyer J. Tolerability and efficacy of a low-volume enteral supplement containing key nutrients in the critically ill. Clin Nutr. 2011 Oct;30(5):599-603. doi: 10.1016/j.clnu.2011.04.003. Epub 2011 May 31.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresubin Original and Intestamin plus Fresubin Original in people with Critical Illness and Adult, run by Hannover Medical School at 1 site in Germany.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 22 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of stay in ICU (time frame: 14 days). 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 NCT01167075, which also lists 1 linked publication.
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 22 Jul 2010.