MedTrace Logo

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

NCT00515736 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2010-07-30

No results posted yet for this study

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. 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.

Conditions

  • Critically Ill Patients
  • Cardiac Surgery
  • Trauma
  • Subarachnoid Hemorrhage

Interventions

DRUG

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

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

DRUG

Placebo

vehicle

Sponsors & Collaborators

  • Fresenius Kabi

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

  • Mette M Berger, MD PhD · Dpt of Adult Intensive Care, CHUV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2005-12-31
Completion
2005-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00515736 on ClinicalTrials.gov