Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma

The University of Alabama at Birmingham

Status and phase: Terminated; Phase 2

Conditions: Coagulopathy; Nosocomial Pneumonia

Treatments: Drug: Placebo (for Vitamin E); Dietary Supplement: Vitamin E; Dietary Supplement: Vitamin C; Dietary Supplement: Saline (for Vitamin C)

Study type: Interventional

Funder types: Other

Identifiers

NCT01897792

F101108001

Details and patient eligibility

About

The purpose of this study is to determine the effect of antioxidant vitamins (vitamins C and E) on the development of coagulation derangements and nosocomial pneumonia after severe trauma in patients.

Enrollment: 11 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult trauma patients admitted to the emergency department at the University of Alabama at Birmingham (UAB) Hospital
• Blunt or penetrating injury
• UAB highest trauma activation

Exclusion criteria

• Age < 19 years of age
• Patients with known bleeding diathesis or who are concurrently taking anticoagulant medication
• Patients with known liver disease
• Minor patients
• Pregnant patients (known or suspected pregnancy)
• Patients who are incarcerated
• Patients who lack a surrogate

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11 participants in 2 patient groups, including a placebo group

Vitamins C and E

Experimental group

Description:

Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.

Treatment:

Dietary Supplement: Vitamin E

Dietary Supplement: Vitamin C

0.9% saline and sugar pill

Placebo Comparator group

Description:

100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.

Treatment:

Drug: Placebo (for Vitamin E)

Dietary Supplement: Saline (for Vitamin C)