Antioxidant Supplementation in Trauma Patients

NCT ID: NCT00613392

Last Updated: 2016-01-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-11-30

Brief Summary

Administration of antioxidants to trauma patients will improve measures of oxidant stress in the blood

Conditions

Multiple Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: EXPERIMENTAL

powdered antioxidant

Intervention Type: DIETARY_SUPPLEMENT

one vial mixed with water every day orally or through enteral tube

2

Group Type: PLACEBO_COMPARATOR

powdered cornstarch placebo

Intervention Type: DIETARY_SUPPLEMENT

one vial mix with water and administer orally or via enteral tube

Interventions

powdered antioxidant

one vial mixed with water every day orally or through enteral tube

Intervention Type: DIETARY_SUPPLEMENT

powdered cornstarch placebo

one vial mix with water and administer orally or via enteral tube

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Adult non pregnant non lactating trauma patient

Exclusion Criteria

• GCS <6
• Renal dysfunction (cre > 2.5 mg/dl)
• Hepatic dysfunction ( TBili > 3.0 mg/dl)
• Expected survival < 48 hours
• Burns over > 20% body surface area
• Immune-deficiency syndromes
• Steroid use

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Burke, MD

Role: STUDY_DIRECTOR

Boston Medical Center

Other Identifiers

H-25038

Identifier Type: -

Identifier Source: org_study_id