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

February 8, 2017 updated by: Jean-Francois Pittet, University of Alabama at Birmingham
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • The University of Alabama at Birmingham Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamins C and E
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.
Dietary supplement: Vitamin C
Other Names:
  • ascorbic acid
Dietary supplement: Vitamin E
Other Names:
  • alpha-tocopherol
Placebo Comparator: 0.9% saline and sugar pill
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.
Dietary supplement: Saline (for Vitamin C)
0.9% saline administered to mimic Vitamin C
Drug: Placebo (for Vitamin E)
Sugar pill administered to mimic Vitamin E

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Coagulation Abnormalities
Time Frame: From enrollment up to 3 days
Coagulation parameters are evaluated using standard functional tests (prothrombin time (PT), partial thromboplastin time (PTT), fibrinogen and platelet count)and point of care functional analysis using thromboelastogram (TEG-ROTEM). A blood sample is collected upon arrival in the emergency department at 0 hours only and analyzed for markers of activation of coagulation, inflammation, and levels of vitamin C/E.
From enrollment up to 3 days
Number of Subjects With Ventilator-associated Pneumonia.
Time Frame: From enrollment to 3 days
Number of subjects diagnosed with pneumonia and requiring ventilator support.
From enrollment to 3 days
Number of Subjects With Organ Injury
Time Frame: From enrollment to 3 days
Any injury to internal organs (thoracic, abdominal or cranial cavity)
From enrollment to 3 days
Number of Total Blood Product Transfusions
Time Frame: From enrollment to 3 days
the number of blood product transfusions for all subjects in each group over the course of 3 days.
From enrollment to 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Protocol Violations Per Arm.
Time Frame: from enrollment up to 60 days post enrollment
The number of times that there was a deviation or violation from how the protocol was to be implemented.
from enrollment up to 60 days post enrollment
Number of Subjects Surviving to Day 28
Time Frame: from enrollment up to 28 days post enrollment
Number of subjects that survived to day 28 after enrollment
from enrollment up to 28 days post enrollment
Number of Subjects With 60-day Survival
Time Frame: from enrollment up to 60 days post enrollment
Number of subjects in each arm that survived to day 60
from enrollment up to 60 days post enrollment
Mean Number of Ventilator-free Days for Subjects
Time Frame: from enrollment up to 60 days post enrollment
The mean number of ventilator free days (not on ventilator) for subjects in each arm
from enrollment up to 60 days post enrollment
Mean Number of Days in ICU.
Time Frame: from enrollment up to 60 days post enrollment
the mean number of days each subject was in the ICU in each arm
from enrollment up to 60 days post enrollment
Mean Number of Hospital Stay Days.
Time Frame: from enrollment up to 60 days post enrollment
The mean number of days subjects were in the hospital in each arm of the study
from enrollment up to 60 days post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Jean-Francois Pittet, M.D., The University of Alabama at Birmingham
  • Principal Investigator: Jeffrey Kerby, M.D., Ph.D., The University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 9, 2013

First Submitted That Met QC Criteria

July 11, 2013

First Posted (Estimate)

July 12, 2013

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F101108001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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