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Clinical Trial of Antioxidant Therapy in Patients With Septic Shock

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ClinicalTrials.gov Identifier: NCT03557229
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Alfredo Aisa Alvarez, American British Cowdray Medical Center

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Oxidative Stress Septic Shock Drug: Melatonin 5 mg Drug: Vitamin C 1 GM Oral Tablet Drug: Vitamin E 400 UNT Drug: N-acetylcysteine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 23, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants Shock

Arm Intervention/treatment
Experimental: Melatonin Drug: Melatonin 5 mg
Oral: 50 mg once daily for 5 days

Experimental: Vitamin C Drug: Vitamin C 1 GM Oral Tablet
Oral: 1 GM every 6 hours for 5 days

Experimental: Vitamin E Drug: Vitamin E 400 UNT
Oral: 400 UNT every 8 hours for 5 days

Experimental: N-acetylcysteine Drug: N-acetylcysteine
Oral: 1200 mg every 12 hours for 5 days

No Intervention: Control



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Nitrates and nitrites levels [ Time Frame: Immediately before treatment and 48 hours after therapy ]
    Oxidative stress

  2. Malondialdehyde levels [ Time Frame: Immediately before treatment and 48 hours after therapy ]
    Lipid peroxidation

  3. Total antioxidant capacity [ Time Frame: Immediately before treatment and 48 hours after therapy ]
    Antioxidant status

  4. Glutathione Peroxidase Enzyme Activity [ Time Frame: Immediately before treatment and 48 hours after therapy ]
    Antioxidant status

  5. Glutathione S-transferase Activity [ Time Frame: Immediately before treatment and 48 hours after therapy ]
    Antioxidant status

  6. Extracellular Superoxide Dismutase Activity [ Time Frame: Immediately before treatment and 48 hours after therapy ]
    Antioxidant status

  7. Glutathione concentration [ Time Frame: Immediately before treatment and 48 hours after therapy ]
    Antioxidant status



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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:

  • 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.

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): NCT03557229


Contacts
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Contact: Alfredo Aisa Alvarez, MD 015511031600 ext 1764 alfredoaisaa@gmail.com
Contact: Gilberto Camarena Alejo, MBA 015511031600 ext 1764 drcamarena@gmail.com

Locations
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Mexico
Centro Médico ABC Recruiting
Mexico City, Mexico, 05300
Contact: Alfredo Aisa Alvarez, MD    015511031600 ext 1764    alfredoaisaa@gmail.com   
Contact: Gilberto Camarena Alejo, MBA    015511031600 ext 1764    drcamarena@gmail.com   
Principal Investigator: Alfredo Aisa Alvarez, MD         
Sub-Investigator: Maria E Soto López, PhD         
Sub-Investigator: Israel Pérez Torres, PhD         
Sub-Investigator: Gilberto Camarena Alejo, MBA         
Sub-Investigator: Juvenal Franco Granillo, MD         
Sponsors and Collaborators
American British Cowdray Medical Center
Investigators
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Principal Investigator: Alfredo Aisa Alvarez, MD American British Cowdray Medical Center

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Responsible Party: Alfredo Aisa Alvarez, Principal Investigator, American British Cowdray Medical Center
ClinicalTrials.gov Identifier: NCT03557229     History of Changes
Other Study ID Numbers: ABC-18-19
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 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
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Alfredo Aisa Alvarez, American British Cowdray Medical Center:
Oxidative Stress
Sepsis
Treatment
Antioxidant therapy

Additional relevant MeSH terms:
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Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Vitamins
Ascorbic Acid
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Melatonin
Acetylcysteine
N-monoacetylcystine
Antioxidants
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Depressants
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antidotes