MedDataX Logo

Impact Of Antioxidant Micronutrients On Intensive Care Unit (ICU) Outcome

NCT ID: NCT00515736

Last Updated: 2010-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critically Ill Patients Cardiac Surgery Trauma Subarachnoid Hemorrhage

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

selenium oxidative stress glutathione peroxidase critically ill outcome supplementation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AOX group

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)

Group Type EXPERIMENTAL

Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E

Intervention Type DRUG

Se 270mcg, Zn 30mg, C 1.1g, B1 100mg, E 300mg

0

Group receiving vehicle solution for 5 days (double dose for 48 hours)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

vehicle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E

Se 270mcg, Zn 30mg, C 1.1g, B1 100mg, E 300mg

Intervention Type DRUG

Placebo

vehicle

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Selenium - Laboratoire Aguettant Zinc - Laboratoire Aguettant, the others generic vehicle - NaCl 0.9% solution

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* adult patients admitted for above diagnosis assessed on admission by the medical team likely to require more than 48 hours of ICU

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fresenius Kabi

INDUSTRY

Sponsor Role collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dept of Adult Intensive Care, CHUV

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mette M Berger, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dpt of Adult Intensive Care, CHUV

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dpt of Adult Intensive Care - CHUV

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 18687132 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CE-102-02

Identifier Type: -

Identifier Source: org_study_id