- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03557229
Clinical Trial of Antioxidant Therapy in Patients With Septic Shock
August 3, 2021 updated by: Alfredo Aisa Alvarez, American British Cowdray Medical Center
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
131
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Mexico City, Mexico, 05300
- Centro Médico ABC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
|
|
EXPERIMENTAL: Vitamin C
|
Oral: 1 GM every 6 hours for 5 days
|
EXPERIMENTAL: Melatonin
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Oral: 50 mg once daily for 5 days
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EXPERIMENTAL: Vitamin E
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Oral: 400 UNT every 8 hours for 5 days
|
EXPERIMENTAL: N-acetylcysteine
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Oral: 1200 mg every 12 hours for 5 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nitrates and nitrites levels
Time Frame: Immediately before treatment and 48 hours after therapy
|
Oxidative stress
|
Immediately before treatment and 48 hours after therapy
|
Malondialdehyde levels
Time Frame: Immediately before treatment and 48 hours after therapy
|
Lipid peroxidation
|
Immediately before treatment and 48 hours after therapy
|
Total antioxidant capacity
Time Frame: Immediately before treatment and 48 hours after therapy
|
Antioxidant status
|
Immediately before treatment and 48 hours after therapy
|
Glutathione Peroxidase Enzyme Activity
Time Frame: Immediately before treatment and 48 hours after therapy
|
Antioxidant status
|
Immediately before treatment and 48 hours after therapy
|
Glutathione S-transferase Activity
Time Frame: Immediately before treatment and 48 hours after therapy
|
Antioxidant status
|
Immediately before treatment and 48 hours after therapy
|
Extracellular Superoxide Dismutase Activity
Time Frame: Immediately before treatment and 48 hours after therapy
|
Antioxidant status
|
Immediately before treatment and 48 hours after therapy
|
Glutathione concentration
Time Frame: Immediately before treatment and 48 hours after therapy
|
Antioxidant status
|
Immediately before treatment and 48 hours after therapy
|
Selenium
Time Frame: Immediately before treatment and 48 hours after therapy
|
Antioxidant status
|
Immediately before treatment and 48 hours after therapy
|
Vitamin C
Time Frame: Immediately before treatment and 48 hours after therapy
|
Antioxidant status
|
Immediately before treatment and 48 hours after therapy
|
Thioredoxin
Time Frame: Immediately before treatment and 48 hours after therapy
|
Antioxidant status
|
Immediately before treatment and 48 hours after therapy
|
Carbonylation
Time Frame: Immediately before treatment and 48 hours after therapy
|
Pro-oxidant status
|
Immediately before treatment and 48 hours after therapy
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TNF-α
Time Frame: Immediately before treatment and 48 hours after therapy
|
Inflammatory Response Pathway
|
Immediately before treatment and 48 hours after therapy
|
IL-1
Time Frame: Immediately before treatment and 48 hours after therapy
|
Inflammatory Response Pathway
|
Immediately before treatment and 48 hours after therapy
|
IL-6
Time Frame: Immediately before treatment and 48 hours after therapy
|
Inflammatory Response Pathway
|
Immediately before treatment and 48 hours after therapy
|
Ionized Ca2+
Time Frame: Immediately before treatment and 48 hours after therapy
|
Electrolytes
|
Immediately before treatment and 48 hours after therapy
|
Ionized Mg2+
Time Frame: Immediately before treatment and 48 hours after therapy
|
Electrolytes
|
Immediately before treatment and 48 hours after therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alfredo Aisa Alvarez, MD, American British Cowdray Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 23, 2018
Primary Completion (ANTICIPATED)
June 1, 2022
Study Completion (ANTICIPATED)
June 1, 2022
Study Registration Dates
First Submitted
May 11, 2018
First Submitted That Met QC Criteria
June 13, 2018
First Posted (ACTUAL)
June 14, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 10, 2021
Last Update Submitted That Met QC Criteria
August 3, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Sepsis
- Shock, Septic
- Shock
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Central Nervous System Depressants
- Antiviral Agents
- Protective Agents
- Micronutrients
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Melatonin
- Vitamin E
- Vitamins
- Acetylcysteine
- N-monoacetylcystine
- Ascorbic Acid
Other Study ID Numbers
- ABC-18-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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