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

Trauma Clinical Trial

— Etude-AOX  

Official title:

Influence Of Early Antioxidant Supplements On Clinical Evolution And Organ Function In Critically Ill Cardiac Surgery, Major Trauma And Subarachnoid Hemorrhage Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00515736
• Other study ID #: CE-102-02
• Status: Terminated
• Phase: Phase 3
• First received: August 13, 2007
• Last updated: July 29, 2010
• Start date: January 2003
• Est. completion date: December 2005

Study information

• Verified date: April 2008
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Drug:
• Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E
Se 270mcg, Zn 30mg, C 1.1g, B1 100mg, E 300mg
• Placebo
vehicle

Locations

Country	Name	City	State
Switzerland	Dpt of Adult Intensive Care - CHUV	Lausanne	VD

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois	Fresenius Kabi

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Berger MM, Soguel L, Shenkin A, Revelly JP, Pinget C, Baines M, Chioléro RL. Influence of early antioxidant supplements on clinical evolution and organ function in critically ill cardiac surgery, major trauma, and subarachnoid hemorrhage patients. Crit Ca — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Organ function (SOFA) with special additional attention to renal function		3 months	Yes
Secondary	Pneumonia, Length of mechanical ventilation-ICU stay-hospital stay, Mortality		3 months	Yes