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Oxidative Stress Expression and Metabolic Imbalance in Critically Ill Polytrauma Patients and the Implications of Antioxidant Therapy on Clinical Outcomes (OSPOL)

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ClinicalTrials.gov Identifier: NCT03218280
Recruitment Status : Unknown
Verified March 2019 by Alexandru Florin Rogobete, Romanian Society of Anesthesia and Intensive Care.
Recruitment status was:  Active, not recruiting
First Posted : July 14, 2017
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
University of Medicine and Pharmacy "Victor Babes" Timisoara
Information provided by (Responsible Party):
Alexandru Florin Rogobete, Romanian Society of Anesthesia and Intensive Care

Brief Summary:
Critically ill polytrauma patients have a number of physiological disorders secondary to trauma, such as systemic inflammatory response (SIRS), adult respiratory distress syndrome (ARDS), sepsis, oxidative stress (OS), and finally the multiple organ dysfunction syndrome (MODS). Another important aspect in terms of clinical outcome is the energy-metabolic status. Numerous studies have shown that implementing antioxidant therapy, capable of reducing the expression of pro-oxidative, pro-inflammatory and energetic-metabolic status, the mortality rate in critical patients decreases statistically significant. In this research paper, will be implemented a multimodal monitoring protocol that covers the use of biochemical, genetics and epigenetics biomarkers and the use of non-invasive medical devices to assess and monitor critical polytrauma patient. Also will be optimized the antioxidant treatment plan according to the needs of each patient.

Condition or disease Intervention/treatment Phase
Oxidative Stress Polytrauma Drug: Vitamin C Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Oxidative Stress Expression and Metabolic Imbalance in Critically Ill Polytrauma Patients and the Implications of Antioxidant Therapy on Clinical Outcomes
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Antioxidant Therapy Drug: Vitamin C
No Intervention: Antioxidant Free



Primary Outcome Measures :
  1. Implications of Vitamin C on level of oxidative stress [ Time Frame: Every 24 hours ]
    Change in baseline inflammatory biomarkers including Lipid expression modifications (HDL, LDL, Triglycerides, Cholesterol, mg%). Inflammation biomarkers (IL-6, Fibrinogen mg%) Protein expression (Total Proteins, Albumins, g) at every 24 hours following first administration of study drug, until the discharge form ICU.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ISS > 16
  • age >18 y

Exclusion Criteria:

  • refused to be enrolled in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218280


Sponsors and Collaborators
Romanian Society of Anesthesia and Intensive Care
University of Medicine and Pharmacy "Victor Babes" Timisoara
Investigators
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Principal Investigator: Alexandru Rogobete, MSc, PhDs, Clinical Researcher Emergency County Hospital Pius Brinzeu, Clinic of Anesthesia and Intensive Care
Study Director: Ovidiu Bedreag, MD, PhD, Assist Prof Victor Babes University of Medicine and Pharmacy Timisoara
Study Chair: Dorel Sandesc, MD, PhD, Prof Romanian Society of Anesthesia and Intensive Care
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Responsible Party: Alexandru Florin Rogobete, Principal Investigator, Romanian Society of Anesthesia and Intensive Care
ClinicalTrials.gov Identifier: NCT03218280    
Other Study ID Numbers: 20161212CA
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexandru Florin Rogobete, Romanian Society of Anesthesia and Intensive Care:
trauma
antioxidant
oxidative stress
Vitamin C
Ascorbic Acid
Additional relevant MeSH terms:
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Multiple Trauma
Wounds and Injuries
Ascorbic Acid
Vitamins
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents