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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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Vitamin C

Vitamin E

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.

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

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


Participant Flow:   Overall Study
    Vitamins C and E   0.9% Saline and Sugar Pill
STARTED   6   5 
COMPLETED   6   5 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Vitamin C

Vitamin E

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.

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

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

Total Total of all reporting groups

Baseline Measures
   Vitamins C and E   0.9% Saline and Sugar Pill   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   5   11 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      2  33.3%      0   0.0%      2  18.2% 
Male      4  66.7%      5 100.0%      9  81.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   6   5   11 


  Outcome Measures

1.  Primary:   Number of Participants With Coagulation Abnormalities   [ Time Frame: From enrollment up to 3 days ]

2.  Primary:   Number of Subjects With Ventilator-associated Pneumonia.   [ Time Frame: From enrollment to 3 days ]

3.  Primary:   Number of Subjects With Organ Injury   [ Time Frame: From enrollment to 3 days ]

4.  Primary:   Number of Total Blood Product Transfusions   [ Time Frame: From enrollment to 3 days ]

5.  Secondary:   Number of Protocol Violations Per Arm.   [ Time Frame: from enrollment up to 60 days post enrollment ]

6.  Secondary:   Number of Subjects Surviving to Day 28   [ Time Frame: from enrollment up to 28 days post enrollment ]

7.  Secondary:   Number of Subjects With 60-day Survival   [ Time Frame: from enrollment up to 60 days post enrollment ]

8.  Secondary:   Mean Number of Ventilator-free Days for Subjects   [ Time Frame: from enrollment up to 60 days post enrollment ]

9.  Secondary:   Mean Number of Days in ICU.   [ Time Frame: from enrollment up to 60 days post enrollment ]

10.  Secondary:   Mean Number of Hospital Stay Days.   [ Time Frame: from enrollment up to 60 days post enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study terminated--inability to recruit patient that met inclusion criteria.


  More Information

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
e-mail: jpittet@uabmc.edu


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