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

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ClinicalTrials.gov Identifier: NCT01897792
Recruitment Status : Terminated (Inability to recruit patients that meet inclusion criteria.)
First Posted : July 12, 2013
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Jean-Francois Pittet, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Coagulopathy
Nosocomial Pneumonia
Interventions Dietary Supplement: Vitamin C
Dietary Supplement: Vitamin E
Dietary Supplement: Saline (for Vitamin C)
Drug: Placebo (for Vitamin E)
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vitamins C and E 0.9% Saline and Sugar Pill
Hide Arm/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.

Vitamin C

Vitamin E

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.

Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C

Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E

Period Title: Overall Study
Started 6 5
Completed 6 5
Not Completed 0 0
Arm/Group Title Vitamins C and E 0.9% Saline and Sugar Pill Total
Hide Arm/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.

Vitamin C

Vitamin E

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.

Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C

Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E

Total of all reporting groups
Overall Number of Baseline Participants 6 5 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
5
 100.0%
11
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Female
2
  33.3%
0
   0.0%
2
  18.2%
Male
4
  66.7%
5
 100.0%
9
  81.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
4
  80.0%
4
  36.4%
White
6
 100.0%
1
  20.0%
7
  63.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 5 participants 11 participants
6 5 11
1.Primary Outcome
Title Number of Participants With Coagulation Abnormalities
Hide Description 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.
Time Frame From enrollment up to 3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins C and E 0.9% Saline and Sugar Pill
Hide Arm/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.

Vitamin C

Vitamin E

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.

Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C

Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E

Overall Number of Participants Analyzed 6 5
Measure Type: Number
Unit of Measure: participants
2 1
2.Primary Outcome
Title Number of Subjects With Ventilator-associated Pneumonia.
Hide Description Number of subjects diagnosed with pneumonia and requiring ventilator support.
Time Frame From enrollment to 3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins C and E 0.9% Saline and Sugar Pill
Hide Arm/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.
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.
Overall Number of Participants Analyzed 6 5
Measure Type: Number
Unit of Measure: participants
4 2
3.Primary Outcome
Title Number of Subjects With Organ Injury
Hide Description Any injury to internal organs (thoracic, abdominal or cranial cavity)
Time Frame From enrollment to 3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins C and E 0.9% Saline and Sugar Pill
Hide Arm/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.
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.
Overall Number of Participants Analyzed 6 5
Measure Type: Number
Unit of Measure: participants
0 0
4.Primary Outcome
Title Number of Total Blood Product Transfusions
Hide Description the number of blood product transfusions for all subjects in each group over the course of 3 days.
Time Frame From enrollment to 3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins C and E 0.9% Saline and Sugar Pill
Hide Arm/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.
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.
Overall Number of Participants Analyzed 6 5
Measure Type: Number
Unit of Measure: blood transfusions
11 5
5.Secondary Outcome
Title Number of Protocol Violations Per Arm.
Hide Description The number of times that there was a deviation or violation from how the protocol was to be implemented.
Time Frame from enrollment up to 60 days post enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin C and E Participants - 0.9% Saline and Sugar Pill Participants - Protocol Violations
Hide Arm/Group Description:
# of protocol deviations
# of protocol deviations
Overall Number of Participants Analyzed 6 5
Measure Type: Number
Unit of Measure: protocol deviations
1 0
6.Secondary Outcome
Title Number of Subjects Surviving to Day 28
Hide Description Number of subjects that survived to day 28 after enrollment
Time Frame from enrollment up to 28 days post enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins C and E 0.9% Saline and Sugar Pill
Hide Arm/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.
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.
Overall Number of Participants Analyzed 6 5
Measure Type: Number
Unit of Measure: participants
6 5
7.Secondary Outcome
Title Number of Subjects With 60-day Survival
Hide Description Number of subjects in each arm that survived to day 60
Time Frame from enrollment up to 60 days post enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins C and E 0.9% Saline and Sugar Pill
Hide Arm/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.
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.
Overall Number of Participants Analyzed 6 5
Measure Type: Number
Unit of Measure: participants
6 5
8.Secondary Outcome
Title Mean Number of Ventilator-free Days for Subjects
Hide Description The mean number of ventilator free days (not on ventilator) for subjects in each arm
Time Frame from enrollment up to 60 days post enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins C and E 0.9% Saline and Sugar Pill
Hide Arm/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.
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.
Overall Number of Participants Analyzed 6 5
Mean (Full Range)
Unit of Measure: days
12
(2 to 23)
6.2
(1 to 17)
9.Secondary Outcome
Title Mean Number of Days in ICU.
Hide Description the mean number of days each subject was in the ICU in each arm
Time Frame from enrollment up to 60 days post enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins C and E 0.9% Saline and Sugar Pill
Hide Arm/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.
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.
Overall Number of Participants Analyzed 6 5
Mean (Full Range)
Unit of Measure: days
15
(3 to 30)
11
(4 to 20)
10.Secondary Outcome
Title Mean Number of Hospital Stay Days.
Hide Description The mean number of days subjects were in the hospital in each arm of the study
Time Frame from enrollment up to 60 days post enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins C and E 0.9% Saline and Sugar Pill
Hide Arm/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.
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.
Overall Number of Participants Analyzed 6 5
Mean (Full Range)
Unit of Measure: days
18.3
(6 to 39)
18.2
(6 to 26)
Time Frame [Not Specified]
Adverse Event Reporting Description No adverse events were collected
 
Arm/Group Title Vitamins C and E 0.9% Saline and Sugar Pill
Hide Arm/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.

Vitamin C

Vitamin E

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.

Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C

Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E

All-Cause Mortality
Vitamins C and E 0.9% Saline and Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vitamins C and E 0.9% Saline and Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Vitamins C and E 0.9% Saline and Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Study terminated--inability to recruit patient that met inclusion criteria.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jean-Francois Pittet, MD
Organization: UAB Department of Anesthesiology
Phone: 205-996-4755
Publications:
Responsible Party: Jean-Francois Pittet, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01897792     History of Changes
Other Study ID Numbers: F101108001
First Submitted: July 9, 2013
First Posted: July 12, 2013
Results First Submitted: October 27, 2015
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017