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

NCT03218280 | Unknown DMC

• 1 other identifier: 20161212CA
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oxidative Stress; Polytrauma

Keywords

trauma; antioxidant; oxidative stress; Vitamin C; Ascorbic Acid

Outcome Measures

Primary Outcomes (1)

• Implications of Vitamin C on level of oxidative stress

  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.

  Every 24 hours

Study Arms (2)

Antioxidant Therapy

ACTIVE COMPARATOR

Drug: Vitamin C

Antioxidant Free

NO INTERVENTION

Interventions

Vitamin C DRUG

Antioxidant Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ISS \> 16
• age \>18 y

You may not qualify if:

• refused to be enrolled in the study

Sponsors & Collaborators

• Romanian Society of Anesthesia and Intensive Care: lead
• University of Medicine and Pharmacy "Victor Babes" Timisoara: collaborator

MeSH Terms

Conditions

Multiple Trauma; Wounds and Injuries

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Alexandru Rogobete, MSc, PhDs, Clinical Researcher

  Emergency County Hospital Pius Brinzeu, Clinic of Anesthesia and Intensive Care

  PRINCIPAL INVESTIGATOR

• Ovidiu Bedreag, MD, PhD, Assist Prof

  Victor Babes University of Medicine and Pharmacy Timisoara

  STUDY DIRECTOR

• Dorel Sandesc, MD, PhD, Prof

  Romanian Society of Anesthesia and Intensive Care

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: July 14, 2017
• Study Start: January 1, 2017
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: March 7, 2019

Record last verified: 2019-03