Oxidative StressOSPOLNCT03218280
Oxidative Stress Expression and Metabolic Imbalance in Critically Ill Polytrauma Patients and the Implications of Antioxidant Therapy on Clinical Outcomes
A study testing Vitamin C in people with Oxidative Stress and Polytrauma, run by Romanian Society of Anesthesia and Intensive Care.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxidative Stress, Polytrauma
- What is being tested?
- Vitamin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ISS > 16
- age >18 y
Who cannot join
- refused to be enrolled in the study
About this study
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.
Read the detailed description
- Objectives The project aims the integration for the first time in Romania of modern monitoring equipment for pro-oxidative, pro-inflammatory status and the energetic-metabolic necessary specific to the departments of anesthesia and intensive care, the clinical and laboratory data, genetic / epigenetic analyzes and existing information for the modulation and optimization of the intensive care for polytrauma patients. This way, the prospect of developing a decision support module for doctors to improve indices of mortality and morbidity in this area will be created. Reducing mortality and increasing quality of care is possible by providing a modern and complex monitoring system for critically ill polytrauma patient followed essentially by the acquisition, interpretation and synthesis in time of these biological signals and correlation with other clinical and laboratory data useful in modulating intensive care. The general objectives are to develop new areas of research in accordance with the trends of international research and with the economic and social romanian and european requirements by creating a integrated, innovative protocol with the improvement in the indices of mortality and morbidity in the intensive care of trauma patient through multimodality monitoring procedures and modulating intensive care management continuously in order to improve the public health system. The specific objectives of the study are the integration of modern methods for monitoring and optimizing therapeutic management depending on the individual patient (individualized management of intensive care); calculating severity and risk scores, both in the first 24 hours and continuously, providing medical decision support tools in real time; developing in an ergonomic, dynamic and standardized for viewing local and remote way the intensive care protocol modulated after modern techniques for non-invasive monitoring and cost-effective in the long term. Advantages of multimodal monitoring of pro-oxidative, pro-inflammatory and energetic-metabolic status through conventional laboratory analyzes, genetic / epigenetic analyzes and indirect calorimetry is represented by the particularly low time for obtaining the results, but also the pool of information brought on regarding the clinical status of these patients. Moreover, secondary it is possible to implement an intensive care that is modulated individually that reflects both on clinical outcome of the patient and the costs. Not least by obtaining a genetic array of specific pathophysiology's polymorphisms (SIRS, sepsis, ARDS, MODS) early and targeted therapies can be implemented that can significantly reduce mortality rates.
- Impact The direct beneficiaries of the study are represented by physicians Department of Anesthesia and Intensive Care County Hospital Emergency "Pius Brinzeu" Timisoara that will have a very useful tool in clinical practice and research with direct impact on patient outcomes (approx. 3000 patients / year). Also, the entire local medical and scientific community: doctors, medical researchers and teachers. Through interdisciplinary nature of the specialty of anesthesia and intensive care, direct beneficiaries of research results in this area are represented by physicians from a wide range of medical specialties: surgery, neurosurgery, cardiology, infectious diseases, orthopedics and traumatology, clinical biology, genetics and so on. They will retrieve new information brought by research, will implement and apply it themselves on a new target groups of patients, thus expanding the distribution area of potential beneficiaries. Lastly, the economic environment through technology transfer from research results to other clinical and experimental centers. The indirect beneficiaries are represented by patients who will benefit directly from the implementation of the clinical trial results of research in anesthesia and intensive care: patients from clinics in the country and possibly abroad. Local and regional community - by improving the quality of medical services for the community, increased quality of life and level of economic and social reintegration of former patients. Local administration by savings from the local budget allocated to health with the implementation of new techniques and thus through reducing hospitalization time in the intensive care unit of these patients.
- Statistical analysis Statistical analyzes will be carried out with specially designed computer equipment such as Prism 6 for Mac OSX v.6.0 (GraphPad Software, Inc., San Diego, CA) and Microsoft Office Excel (Microsoft Corporation, Bucharest, Romania). Statistical analysis of data recorded in the database will be to calculate frequencies and percentages for quantitative variables. Also, for the quantitative variables, the results will be expressed as the mean and standard deviation. Statistical comparisons used for test environments will be calculated with the unpaired t-test and for statistical comparisons used percentages using Chi square test. Statistical significance will be defined at p <0.05.
- Conditions
- Oxidative Stress, Polytrauma
- Being tested
- Vitamin C
- Keywords
- trauma, antioxidant, oxidative stress, Vitamin C, Ascorbic Acid
- Medical subject headings
- Multiple Trauma, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
| Study group | Role | What they receive |
|---|---|---|
| Antioxidant Therapy | Active comparator | Not described Receives: Drug: Vitamin C |
| Antioxidant Free | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start1 Jan 2017
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Romanian Society of Anesthesia and Intensive Care
- Sponsor type
- University, hospital or other
- Collaborators
- University of Medicine and Pharmacy "Victor Babes" Timisoara
- Responsible party
- Principal investigator, Alexandru Florin Rogobete, Romanian Society of Anesthesia and Intensive Care
- Investigators
- Alexandru Rogobete, MSc, PhDs, Clinical Researcher, Principal investigator, Emergency County Hospital Pius Brinzeu, Clinic of Anesthesia and Intensive CareOvidiu Bedreag, MD, PhD, Assist Prof, Study director, Victor Babes University of Medicine and Pharmacy TimisoaraDorel Sandesc, MD, PhD, Prof, Study chair, Romanian Society of Anesthesia and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218280
- Sponsor's protocol ID
- 20161212CA
- Acronym
- OSPOL
- Status last verified
- Mar 2019
- First submitted
- 3 Apr 2017
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress Expression and Metabolic Imbalance in Critically Ill Polytrauma Patients and the Implications of Antioxidant Therapy on Clinical Outcomes
- ClinicalTrials.gov ID
- NCT03218280
- Acronym / sponsor ID
- OSPOL / 20161212CA
- Conditions
- Oxidative Stress, Polytrauma
- Keywords
- trauma, antioxidant, oxidative stress, Vitamin C, Ascorbic Acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Romanian Society of Anesthesia and Intensive CareUniversity, hospital or other
- Collaborators
- University of Medicine and Pharmacy "Victor Babes" Timisoara
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Objectives The project aims the integration for the first time in Romania of modern monitoring equipment for pro-oxidative, pro-inflammatory status and the energetic-metabolic necessary specific to the departments of anesthesia and intensive care, the clinical and laboratory data, genetic / epigenetic analyzes and existing information for the modulation and optimization of the intensive care for polytrauma patients. This way, the prospect of developing a decision support module for doctors to improve indices of mortality and morbidity in this area will be created. Reducing mortality and increasing quality of care is possible by providing a modern and complex monitoring system for critically ill polytrauma patient followed essentially by the acquisition, interpretation and synthesis in time of these biological signals and correlation with other clinical and laboratory data useful in modulating intensive care. The general objectives are to develop new areas of research in accordance with the trends of international research and with the economic and social romanian and european requirements by creating a integrated, innovative protocol with the improvement in the indices of mortality and morbidity in the intensive care of trauma patient through multimodality monitoring procedures and modulating intensive care management continuously in order to improve the public health system. The specific objectives of the study are the integration of modern methods for monitoring and optimizing therapeutic management depending on the individual patient (individualized management of intensive care); calculating severity and risk scores, both in the first 24 hours and continuously, providing medical decision support tools in real time; developing in an ergonomic, dynamic and standardized for viewing local and remote way the intensive care protocol modulated after modern techniques for non-invasive monitoring and cost-effective in the long term. Advantages of multimodal monitoring of pro-oxidative, pro-inflammatory and energetic-metabolic status through conventional laboratory analyzes, genetic / epigenetic analyzes and indirect calorimetry is represented by the particularly low time for obtaining the results, but also the pool of information brought on regarding the clinical status of these patients. Moreover, secondary it is possible to implement an intensive care that is modulated individually that reflects both on clinical outcome of the patient and the costs. Not least by obtaining a genetic array of specific pathophysiology's polymorphisms (SIRS, sepsis, ARDS, MODS) early and targeted therapies can be implemented that can significantly reduce mortality rates.
- Impact The direct beneficiaries of the study are represented by physicians Department of Anesthesia and Intensive Care County Hospital Emergency "Pius Brinzeu" Timisoara that will have a very useful tool in clinical practice and research with direct impact on patient outcomes (approx. 3000 patients / year). Also, the entire local medical and scientific community: doctors, medical researchers and teachers. Through interdisciplinary nature of the specialty of anesthesia and intensive care, direct beneficiaries of research results in this area are represented by physicians from a wide range of medical specialties: surgery, neurosurgery, cardiology, infectious diseases, orthopedics and traumatology, clinical biology, genetics and so on. They will retrieve new information brought by research, will implement and apply it themselves on a new target groups of patients, thus expanding the distribution area of potential beneficiaries. Lastly, the economic environment through technology transfer from research results to other clinical and experimental centers. The indirect beneficiaries are represented by patients who will benefit directly from the implementation of the clinical trial results of research in anesthesia and intensive care: patients from clinics in the country and possibly abroad. Local and regional community - by improving the quality of medical services for the community, increased quality of life and level of economic and social reintegration of former patients. Local administration by savings from the local budget allocated to health with the implementation of new techniques and thus through reducing hospitalization time in the intensive care unit of these patients.
- Statistical analysis Statistical analyzes will be carried out with specially designed computer equipment such as Prism 6 for Mac OSX v.6.0 (GraphPad Software, Inc., San Diego, CA) and Microsoft Office Excel (Microsoft Corporation, Bucharest, Romania). Statistical analysis of data recorded in the database will be to calculate frequencies and percentages for quantitative variables. Also, for the quantitative variables, the results will be expressed as the mean and standard deviation. Statistical comparisons used for test environments will be calculated with the unpaired t-test and for statistical comparisons used percentages using Chi square test. Statistical significance will be defined at p <0.05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antioxidant Therapy | Active comparator | Drug: Vitamin C |
| Antioxidant Free | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ISS > 16
- age >18 y
Key exclusion criteria (1 listed)
- refused to be enrolled in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C | Drug | Antioxidant Therapy |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandru Rogobete, MSc, PhDs, Clinical Researcher principal investigator
Emergency County Hospital Pius Brinzeu, Clinic of Anesthesia and Intensive Care
Ovidiu Bedreag, MD, PhD, Assist Prof study director
Victor Babes University of Medicine and Pharmacy Timisoara
Dorel Sandesc, MD, PhD, Prof study chair
Romanian Society of Anesthesia and Intensive Care
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with Oxidative Stress and Polytrauma, run by Romanian Society of Anesthesia and Intensive Care.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implications of Vitamin C on level of oxidative stress (time frame: Every 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.