ICU PatientsPhase 4NCT00922714
Scandinavian Intensive Care Unit (ICU) Glutamine Study
A Phase 4 study testing Glutamine in people with ICU Patients, run by Scandinavian Critical Care Trials Group at 1 site in Sweden.
Trial summary
This is a prospective double-blinded placebo-controlled block randomized study in intensive care patients comparing intravenous glutamine supplementation to placebo. The hypothesis is an improvement of clinical outcome. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ICU Patients
- What is being tested?
- Glutamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2003to Aug 2009
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admission to the ICU
- decision to give the patient full nutrition
- APACHE II score > 10 at admission
- age 18-85 years
Who cannot join
- readmission to the ICU after a previous ICU-stay in which the patient has been included into the study
- subjects with any condition which in the opinion of the attending physician makes the subject unsuitable for inclusion
- no informed consent
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Intensive Care Unit, Karolinska University Hospital Huddinge
Stockholm, 14186
About this study
Official title: Glutamine to Intensive Care Patients - a Prospective, Double-Blind, Placebo-Controlled Multicenter Study in the Scandinavian Countries
This is a prospective double-blinded placebo-controlled block randomized study in intensive care patients comparing intravenous glutamine supplementation to placebo. The hypothesis is an improvement of clinical outcome. The primary endpoint is a reduction in the Sequential Organ Failure Assessment (SOFA) score on day 7 of treatment.
Read the detailed description
This is a prospective double-blinded placebo-controlled block randomised study in intensive care patients comparing intravenous glutamine supplementation (0.285 g/kg body weight/24 h) to placebo. Inclusion criteria are patients treated for more than 3 days. Primary endpoint is a reduction in SOFA-score on day 7 of treatments. Secondary endpoints are: ICU-mortality, 6-months mortality, length of ICU stay, organ failure free days as well as reduction in SOFA-score on day 10 of treatment. Nutrition will be standardised so that not less than 80% of the target which is basal energy expenditure according to Harris \& Benedict is given daily. Enteral nutrition is preferred, but a combination of enteral and parenteral nutrition is recommended to achieve the nutritional target. For statistical comparison non-parametric rank order statistics will be used. To detect a 0.75-point difference in the reduction of SOFA-score on day 7 of treatment, a total of 1,000 patients will be needed.
- Conditions
- ICU Patients
- Being tested
- Glutamine, saline (placebo)
- Keywords
- Glutamine, ICU patients, Critically ill, Nutrition
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDrug
Also called L-alanyl-L-glutamine, Dipeptiven
Intravenous glutamine supplementation (0.285 g/kg body weight/24 h)
saline (placebo)Drug
NaCl 0.9 g/L
| Study group | Role | What they receive |
|---|---|---|
| Glutamine | Experimental | Intravenous glutamine supplementation (0.285 g/kg body weight/24 h) Receives: Drug: Glutamine |
| Control | Placebo comparator | saline Receives: Drug: saline (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A reduction in SOFA-score
Measured: Day 7 of treatment
Secondary outcomes (4)
Mortality
Measured: ICU stay and 6 months
Length of ICU stay
Measured: ICU stay
Organ failure free days
Measured: ICU stay
Reduction in SOFA-score
Measured: Day 10 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startOct 2003
- Primary completionMay 2007
- Study completionAug 2009 (estimated)
Why it stopped: Slow recruitment, stopped after 4 years
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU PatientsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scandinavian Critical Care Trials Group
- Sponsor type
- University, hospital or other
- Investigators
- Jan Wernerman, MD, PhD, Principal investigator, Dept Anesthesiology and Intensive Care Medicine, KArolinska University Hospital Huddinge, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922714
- Sponsor's protocol ID
- Scandinavian Glutamin Study
- Status last verified
- Jun 2009
- First submitted
- 15 Jun 2009
- Last updated
- 17 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutamine to Intensive Care Patients - a Prospective, Double-Blind, Placebo-Controlled Multicenter Study in the Scandinavian Countries
- ClinicalTrials.gov ID
- NCT00922714
- Acronym / sponsor ID
- Scandinavian Glutamin Study
- Conditions
- ICU Patients
- Keywords
- Glutamine, ICU patients, Critically ill, Nutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment, stopped after 4 years
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Scandinavian Critical Care Trials GroupUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- May 2007 (actual)
- Study completion
- Aug 2009 (estimated)
- First posted
- 17 Jun 2009 (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.
This is a prospective double-blinded placebo-controlled block randomized study in intensive care patients comparing intravenous glutamine supplementation to placebo. The hypothesis is an improvement of clinical outcome. The primary endpoint is a reduction in the Sequential Organ Failure Assessment (SOFA) score on day 7 of treatment.
Detailed description
This is a prospective double-blinded placebo-controlled block randomised study in intensive care patients comparing intravenous glutamine supplementation (0.285 g/kg body weight/24 h) to placebo. Inclusion criteria are patients treated for more than 3 days. Primary endpoint is a reduction in SOFA-score on day 7 of treatments. Secondary endpoints are: ICU-mortality, 6-months mortality, length of ICU stay, organ failure free days as well as reduction in SOFA-score on day 10 of treatment. Nutrition will be standardised so that not less than 80% of the target which is basal energy expenditure according to Harris \& Benedict is given daily. Enteral nutrition is preferred, but a combination of enteral and parenteral nutrition is recommended to achieve the nutritional target. For statistical comparison non-parametric rank order statistics will be used. To detect a 0.75-point difference in the reduction of SOFA-score on day 7 of treatment, a total of 1,000 patients will be needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glutamine | Experimental | Drug: GlutamineIntravenous glutamine supplementation (0.285 g/kg body weight/24 h) |
| Control | Placebo comparator | Drug: saline (placebo)saline |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- admission to the ICU
- decision to give the patient full nutrition
- APACHE II score > 10 at admission
- age 18-85 years
Key exclusion criteria (3 listed)
- readmission to the ICU after a previous ICU-stay in which the patient has been included into the study
- subjects with any condition which in the opinion of the attending physician makes the subject unsuitable for inclusion
- no informed consent
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 |
|---|---|---|
| GlutamineAlso: L-alanyl-L-glutamine, DipeptivenIntravenous glutamine supplementation (0.285 g/kg body weight/24 h) | Drug | Glutamine |
| saline (placebo)NaCl 0.9 g/L | Drug | Control |
Primary outcome
A reduction in SOFA-score
Time frame: Day 7 of treatment
4 secondary outcomes
Mortality
Time frame: ICU stay and 6 months
Length of ICU stay
Time frame: ICU stay
Organ failure free days
Time frame: ICU stay
Reduction in SOFA-score
Time frame: Day 10 of treatment
Results and safety
The study was stopped early (reason given: Slow recruitment, stopped after 4 years). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2009.
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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.
Jan Wernerman, MD, PhD principal investigator
Dept Anesthesiology and Intensive Care Medicine, KArolinska University Hospital Huddinge, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glutamine in people with ICU Patients, run by Scandinavian Critical Care Trials Group at 1 site in Sweden.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 17 Jun 2009. 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 Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment, stopped after 4 years). Results are not available in the source record.
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?
A reduction in SOFA-score (time frame: Day 7 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2009.