Oxidative StressPhase 3NCT03557229
Clinical Trial of Antioxidant Therapy in Patients With Septic Shock
A Phase 3 study testing Melatonin 5 mg, Vitamin C 1 GM Oral Tablet and Vitamin E 400 UNT in people with Oxidative Stress and Septic Shock, run by American British Cowdray Medical Center at 1 site in Mexico.
Trial summary
Sepsis and septic shock are public health problems worldwide that represents an excessive cost for health systems. Despite the great technological and research advances, mortality can reach up to 80% in patients with multiple organ failure (FOM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxidative Stress, Septic Shock
- What is being tested?
- Melatonin 5 mg, Vitamin C 1 GM Oral Tablet and Vitamin E 400 UNT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteMexico
- Study dates
- 23 Jul 2018to Jun 2022
- Phase
- Phase 3
- 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
- Diagnosis of septic shock in the last 24 hours characterized by refractory hypotension and vasopressor requirement despite sufficient fluid resuscitation (20 mL/kg of colloids or 40 mL/kg of crystalloids) to maintain a blood pressure ≥ 65 mmHg with a lactate> 2 mmol/L.
- Admitted to the ICU of the ABC Medical Center.
- Give informed consent.
Who cannot join
- Patients who refuse to be included.
- Chronic or recent use of steroids.
- Use of statins.
- Patients receiving some type of antioxidant treatment.
- Any contraindication to the use of vitamin C, vitamin E, n-acetylcysteine or melatonin.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Clinical Trial of Antioxidant Therapy in Critically Ill Patients With Septic Shock: Analysis Before and After Treatment of the Oxidative Stress
Sepsis and septic shock are public health problems worldwide that represents an excessive cost for health systems. Despite the great technological and research advances, mortality can reach up to 80% in patients with multiple organ failure (FOM). Therapeutic studies focused on evaluating the usefulness of the use of antioxidants have shown different outcomes and results. This randomized clinical trial in patients with septic shock at two general intensive care units try to evaluate the usefulness of four different antioxidant therapies added to the conventional treatment, which includes: n-acetyl cysteine, vitamin C, vitamin E and melatonin. Measurement of parameters before and after treatment of oxidative stress includes nitrates and nitrites, lipid peroxidation, glutathione peroxidase, glutathione s transferase, extracellular activity of SOD, GSH concentration and evaluation of total antioxidant capacity. The investigators will also evaluate the clinical impact of antioxidant therapy with the SOFA score.
- Conditions
- Oxidative Stress, Septic Shock
- Being tested
- Melatonin 5 mg, Vitamin C 1 GM Oral Tablet, Vitamin E 400 UNT, N-acetylcysteine
- Keywords
- Oxidative Stress, Sepsis, Treatment, Antioxidant therapy
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 5 mgDrug
Oral: 50 mg once daily for 5 days
Vitamin C 1 GM Oral TabletDrug
Oral: 1 GM every 6 hours for 5 days
Vitamin E 400 UNTDrug
Oral: 400 UNT every 8 hours for 5 days
N-acetylcysteineDrug
Oral: 1200 mg every 12 hours for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Not described Receives: Drug: Melatonin 5 mg |
| Vitamin C | Experimental | Not described Receives: Drug: Vitamin C 1 GM Oral Tablet |
| Vitamin E | Experimental | Not described Receives: Drug: Vitamin E 400 UNT |
| N-acetylcysteine | Experimental | Not described Receives: Drug: N-acetylcysteine |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organic failure measurement by the Sequential Organ Failure Assessment Score (SOFA)
The SOFA score is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The worst physiological variables is collected serially every 24 hours of a patient's ICU admission. The "worst" measurement is defined as the measure that correlated to the highest number of points. The SOFA score ranges from 0 to 24. The investigators are going to evaluate the daily total score and the trend before and after the administration of the therapy.
Measured: Up to 7 days (1 week). From date of randomization and every 24 hours until discharge from the intensive care unit or date of death from any cause, whichever came first, assessed up to 7 days.
Secondary outcomes (11)
Nitrates and nitrites levels
Oxidative stress
Measured: Immediately before treatment and 48 hours after therapy
Malondialdehyde levels
Lipid peroxidation
Measured: Immediately before treatment and 48 hours after therapy
Total antioxidant capacity
Antioxidant status
Measured: Immediately before treatment and 48 hours after therapy
Glutathione Peroxidase Enzyme Activity
Antioxidant status
Measured: Immediately before treatment and 48 hours after therapy
Glutathione S-transferase Activity
Antioxidant status
Measured: Immediately before treatment and 48 hours after therapy
Extracellular Superoxide Dismutase Activity
Antioxidant status
Measured: Immediately before treatment and 48 hours after therapy
Glutathione concentration
Antioxidant status
Measured: Immediately before treatment and 48 hours after therapy
Selenium
Antioxidant status
Measured: Immediately before treatment and 48 hours after therapy
Vitamin C
Antioxidant status
Measured: Immediately before treatment and 48 hours after therapy
Thioredoxin
Antioxidant status
Measured: Immediately before treatment and 48 hours after therapy
Carbonylation
Pro-oxidant status
Measured: Immediately before treatment and 48 hours after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start23 Jul 2018
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American British Cowdray Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfredo Aisa Alvarez, American British Cowdray Medical Center
- Investigators
- Alfredo Aisa Alvarez, MD, Principal investigator, American British Cowdray Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557229
- Sponsor's protocol ID
- ABC-18-19
- Status last verified
- Aug 2021
- First submitted
- 11 May 2018
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aisa-Alvarez A, Perez-Torres I, Guarner-Lans V, Manzano-Pech L, Cruz-Soto R, Marquez-Velasco R, Casarez-Alvarado S, Franco-Granillo J, Nunez-Martinez ME, Soto ME. Randomized Clinical Trial of Antioxidant Therapy Patients with Septic Shock and Organ Dysfunction in the ICU: SOFA Score Reduction by Improvement of the Enzymatic and Non-Enzymatic Antioxidant System. Cells. 2023 May 6;12(9):1330. doi: 10.3390/cells12091330.
PubMed 37174730
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial of Antioxidant Therapy in Critically Ill Patients With Septic Shock: Analysis Before and After Treatment of the Oxidative Stress
- ClinicalTrials.gov ID
- NCT03557229
- Acronym / sponsor ID
- ABC-18-19
- Conditions
- Oxidative Stress, Septic Shock
- Keywords
- Oxidative Stress, Sepsis, Treatment, Antioxidant therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- American British Cowdray Medical CenterUniversity, hospital or other
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 14 Jun 2018 (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.
Sepsis and septic shock are public health problems worldwide that represents an excessive cost for health systems. Despite the great technological and research advances, mortality can reach up to 80% in patients with multiple organ failure (FOM). Therapeutic studies focused on evaluating the usefulness of the use of antioxidants have shown different outcomes and results. This randomized clinical trial in patients with septic shock at two general intensive care units try to evaluate the usefulness of four different antioxidant therapies added to the conventional treatment, which includes: n-acetyl cysteine, vitamin C, vitamin E and melatonin. Measurement of parameters before and after treatment of oxidative stress includes nitrates and nitrites, lipid peroxidation, glutathione peroxidase, glutathione s transferase, extracellular activity of SOD, GSH concentration and evaluation of total antioxidant capacity. The investigators will also evaluate the clinical impact of antioxidant therapy with the SOFA score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: Melatonin 5 mg |
| Vitamin C | Experimental | Drug: Vitamin C 1 GM Oral Tablet |
| Vitamin E | Experimental | Drug: Vitamin E 400 UNT |
| N-acetylcysteine | Experimental | Drug: N-acetylcysteine |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of septic shock in the last 24 hours characterized by refractory hypotension and vasopressor requirement despite sufficient fluid resuscitation (20 mL/kg of colloids or 40 mL/kg of crystalloids) to maintain a blood pressure ≥ 65 mmHg with a lactate> 2 mmol/L.
- Admitted to the ICU of the ABC Medical Center.
- Give informed consent.
Key exclusion criteria (6 listed)
- Patients who refuse to be included.
- Chronic or recent use of steroids.
- Use of statins.
- Patients receiving some type of antioxidant treatment.
- Any contraindication to the use of vitamin C, vitamin E, n-acetylcysteine or melatonin.
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 |
|---|---|---|
| Melatonin 5 mgOral: 50 mg once daily for 5 days | Drug | Melatonin |
| Vitamin C 1 GM Oral TabletOral: 1 GM every 6 hours for 5 days | Drug | Vitamin C |
| Vitamin E 400 UNTOral: 400 UNT every 8 hours for 5 days | Drug | Vitamin E |
| N-acetylcysteineOral: 1200 mg every 12 hours for 5 days | Drug | N-acetylcysteine |
Primary outcome
Organic failure measurement by the Sequential Organ Failure Assessment Score (SOFA)
Time frame: Up to 7 days (1 week). From date of randomization and every 24 hours until discharge from the intensive care unit or date of death from any cause, whichever came first, assessed up to 7 days.
The SOFA score is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The worst physiological variables is collected serially every 24 hours of a patient's ICU admission. The "worst" measurement is defined as the measure that correlated to the highest number of points. The SOFA score ranges from 0 to 24. The investigators are going to evaluate the daily total score and the trend before and after the administration of the therapy.
11 secondary outcomes
Nitrates and nitrites levels
Time frame: Immediately before treatment and 48 hours after therapy
Malondialdehyde levels
Time frame: Immediately before treatment and 48 hours after therapy
Total antioxidant capacity
Time frame: Immediately before treatment and 48 hours after therapy
Glutathione Peroxidase Enzyme Activity
Time frame: Immediately before treatment and 48 hours after therapy
Glutathione S-transferase Activity
Time frame: Immediately before treatment and 48 hours after therapy
Extracellular Superoxide Dismutase Activity
Time frame: Immediately before treatment and 48 hours after therapy
Glutathione concentration
Time frame: Immediately before treatment and 48 hours after therapy
Selenium
Time frame: Immediately before treatment and 48 hours after therapy
Vitamin C
Time frame: Immediately before treatment and 48 hours after therapy
Thioredoxin
Time frame: Immediately before treatment and 48 hours after therapy
Carbonylation
Time frame: Immediately before treatment and 48 hours after therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Derived from this study: PubMed 37174730Aisa-Alvarez A, Perez-Torres I, Guarner-Lans V, Manzano-Pech L, Cruz-Soto R, Marquez-Velasco R, Casarez-Alvarado S, Franco-Granillo J, Nunez-Martinez ME, Soto ME. Randomized Clinical Trial of Antioxidant Therapy Patients with Septic Shock and Organ Dysfunction in the ICU: SOFA Score Reduction by Improvement of the Enzymatic and Non-Enzymatic Antioxidant System. Cells. 2023 May 6;12(9):1330. doi: 10.3390/cells12091330.
- 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.
Alfredo Aisa Alvarez, MD principal investigator
American British Cowdray Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Melatonin 5 mg, Vitamin C 1 GM Oral Tablet and Vitamin E 400 UNT in people with Oxidative Stress and Septic Shock, run by American British Cowdray Medical Center at 1 site in Mexico.
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 3 inclusion and 6 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 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Organic failure measurement by the Sequential Organ Failure Assessment Score (SOFA) (time frame: Up to 7 days (1 week). From date of randomization and every 24 hours until discharge from the intensive care unit or date of death from any cause, whichever came first, assessed up to 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03557229, which also lists 1 linked publication.
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 10 Aug 2021.