Critically Ill PatientsPhase 3Etude-AOXNCT00515736
Impact Of Antioxidant Micronutrients On Intensive Care Unit (ICU) Outcome
A Phase 3 study testing Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E in people with Critically Ill Patients and Cardiac Surgery, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Critically ill patients are generally exposed to an increased oxidative stress, which is proportional to the severity of their condition. Endogenous antioxidant (AOX) defenses are depleted particularly in those patients with intense inflammatory response. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critically Ill Patients, Cardiac Surgery, Trauma
- What is being tested?
- Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2003to Dec 2005
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients admitted for above diagnosis assessed on admission by the medical team likely to require more than 48 hours of ICU
Who cannot join
- absence of consent, participation in another study, liver cirrhosis or major burns and life expectancy < 24 hours or a lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the 48 hours
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dpt of Adult Intensive Care - CHUV
Lausanne, Canton of Vaud, 1011
About this study
Official title: Influence Of Early Antioxidant Supplements On Clinical Evolution And Organ Function In Critically Ill Cardiac Surgery, Major Trauma And Subarachnoid Hemorrhage Patients
Critically ill patients are generally exposed to an increased oxidative stress, which is proportional to the severity of their condition. Endogenous antioxidant (AOX) defenses are depleted particularly in those patients with intense inflammatory response. The hypothesis tested is that early I:V: administration of a combination of AOX micronutrient supplements (Se, Zn, Vit C, Vit E, Vit B1) would improve clinical outcome in selected critically ill patients, by reinforcing the endogenous AOX defenses and reducing organ failure.
Read the detailed description
Prospective randomized, double-blind, placebo-controlled, single-center trial. Patients admitted to ICU after complicated cardiac surgery, major trauma with or without brain injury, subarachnoid hemorrhage, and predicted by the clinicians to require >48 hours of ICU treatment.
Supplements: provided IV for 5 days
- Being tested
- Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E, Placebo
- Keywords
- selenium, oxidative stress, glutathione peroxidase, critically ill, outcome, supplementation
- Medical subject headings
- Wounds and Injuries, Subarachnoid Hemorrhage, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin EDrug
Also called Selenium - Laboratoire Aguettant, Zinc - Laboratoire Aguettant, the others generic
Se 270mcg, Zn 30mg, C 1.1g, B1 100mg, E 300mg
PlaceboDrug
Also called vehicle - NaCl 0.9% solution
vehicle
| Study group | Role | What they receive |
|---|---|---|
| AOX group | Experimental | Treatment group - double dose (loading) for 48 hours then single dose (Se 270 mcg, Zn 30 mg, vit C 1.2 g, B1 100 mg, vit E 300 mg enteral) Receives: Drug: Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E |
| 0 | Placebo comparator | Group receiving vehicle solution for 5 days (double dose for 48 hours) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organ function (SOFA) with special additional attention to renal function
Measured: 3 months
Secondary outcomes (1)
Pneumonia, Length of mechanical ventilation-ICU stay-hospital stay, Mortality
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startJan 2003
- Primary completionDec 2005
- Study completionDec 2005
Why it stopped: enrollment was completed
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 Critically Ill PatientsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi
- Investigators
- Mette M Berger, MD PhD, Principal investigator, Dpt of Adult Intensive Care, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515736
- Sponsor's protocol ID
- CE-102-02
- Acronym
- Etude-AOX
- Status last verified
- Apr 2008
- First submitted
- 13 Aug 2007
- Last updated
- 30 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berger MM, Soguel L, Shenkin A, Revelly JP, Pinget C, Baines M, Chiolero RL. Influence of early antioxidant supplements on clinical evolution and organ function in critically ill cardiac surgery, major trauma, and subarachnoid hemorrhage patients. Crit Care. 2008;12(4):R101. doi: 10.1186/cc6981. Epub 2008 Aug 7.
PubMed 18687132
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence Of Early Antioxidant Supplements On Clinical Evolution And Organ Function In Critically Ill Cardiac Surgery, Major Trauma And Subarachnoid Hemorrhage Patients
- ClinicalTrials.gov ID
- NCT00515736
- Acronym / sponsor ID
- Etude-AOX / CE-102-02
- Keywords
- selenium, oxidative stress, glutathione peroxidase, critically ill, outcome, supplementation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment was completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- Fresenius Kabi
- Study start
- Jan 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 14 Aug 2007 (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.
Critically ill patients are generally exposed to an increased oxidative stress, which is proportional to the severity of their condition. Endogenous antioxidant (AOX) defenses are depleted particularly in those patients with intense inflammatory response. The hypothesis tested is that early I:V: administration of a combination of AOX micronutrient supplements (Se, Zn, Vit C, Vit E, Vit B1) would improve clinical outcome in selected critically ill patients, by reinforcing the endogenous AOX defenses and reducing organ failure.
Detailed description
Prospective randomized, double-blind, placebo-controlled, single-center trial. Patients admitted to ICU after complicated cardiac surgery, major trauma with or without brain injury, subarachnoid hemorrhage, and predicted by the clinicians to require >48 hours of ICU treatment.
Supplements: provided IV for 5 days
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AOX group | Experimental | Drug: Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin ETreatment group - double dose (loading) for 48 hours then single dose (Se 270 mcg, Zn 30 mg, vit C 1.2 g, B1 100 mg, vit E 300 mg enteral) |
| 0 | Placebo comparator | Drug: PlaceboGroup receiving vehicle solution for 5 days (double dose for 48 hours) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients admitted for above diagnosis assessed on admission by the medical team likely to require more than 48 hours of ICU
Key exclusion criteria (1 listed)
- absence of consent, participation in another study, liver cirrhosis or major burns and life expectancy < 24 hours or a lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the 48 hours
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 |
|---|---|---|
| Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin EAlso: Selenium - Laboratoire Aguettant, Zinc - Laboratoire Aguettant, the others genericSe 270mcg, Zn 30mg, C 1.1g, B1 100mg, E 300mg | Drug | AOX group |
| PlaceboAlso: vehicle - NaCl 0.9% solutionvehicle | Drug | 0 |
Primary outcome
Organ function (SOFA) with special additional attention to renal function
Time frame: 3 months
1 secondary outcome
Pneumonia, Length of mechanical ventilation-ICU stay-hospital stay, Mortality
Time frame: 3 months
Results and safety
The study was stopped early (reason given: enrollment was completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2010.
- Results publication: PubMed 18687132Berger MM, Soguel L, Shenkin A, Revelly JP, Pinget C, Baines M, Chiolero RL. Influence of early antioxidant supplements on clinical evolution and organ function in critically ill cardiac surgery, major trauma, and subarachnoid hemorrhage patients. Crit Care. 2008;12(4):R101. doi: 10.1186/cc6981. Epub 2008 Aug 7.
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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.
Mette M Berger, MD PhD principal investigator
Dpt of Adult Intensive Care, CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E in people with Critically Ill Patients and Cardiac Surgery, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 1 inclusion and 1 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 30 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 Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: enrollment was completed). 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?
Organ function (SOFA) with special additional attention to renal function (time frame: 3 months). 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 NCT00515736, 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 30 Jul 2010.