Clinical Trial of Antioxidant Therapy in Patients With Septic Shock

Overview

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.

Full Title of Study: “Randomized Controlled Clinical Trial of Antioxidant Therapy in Critically Ill Patients With Septic Shock: Analysis Before and After Treatment of the Oxidative Stress”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2022

Interventions

  • Drug: Melatonin 5 mg
    • Oral: 50 mg once daily for 5 days
  • Drug: Vitamin C 1 GM Oral Tablet
    • Oral: 1 GM every 6 hours for 5 days
  • Drug: Vitamin E 400 UNT
    • Oral: 400 UNT every 8 hours for 5 days
  • Drug: N-acetylcysteine
    • Oral: 1200 mg every 12 hours for 5 days

Arms, Groups and Cohorts

  • Experimental: Melatonin
  • Experimental: Vitamin C
  • Experimental: Vitamin E
  • Experimental: N-acetylcysteine
  • No Intervention: Control

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Nitrates and nitrites levels
    • Time Frame: Immediately before treatment and 48 hours after therapy
    • Oxidative stress
  • Malondialdehyde levels
    • Time Frame: Immediately before treatment and 48 hours after therapy
    • Lipid peroxidation
  • Total antioxidant capacity
    • Time Frame: Immediately before treatment and 48 hours after therapy
    • Antioxidant status
  • Glutathione Peroxidase Enzyme Activity
    • Time Frame: Immediately before treatment and 48 hours after therapy
    • Antioxidant status
  • Glutathione S-transferase Activity
    • Time Frame: Immediately before treatment and 48 hours after therapy
    • Antioxidant status
  • Extracellular Superoxide Dismutase Activity
    • Time Frame: Immediately before treatment and 48 hours after therapy
    • Antioxidant status
  • Glutathione concentration
    • Time Frame: Immediately before treatment and 48 hours after therapy
    • Antioxidant status
  • Selenium
    • Time Frame: Immediately before treatment and 48 hours after therapy
    • Antioxidant status
  • Vitamin C
    • Time Frame: Immediately before treatment and 48 hours after therapy
    • Antioxidant status
  • Thioredoxin
    • Time Frame: Immediately before treatment and 48 hours after therapy
    • Antioxidant status
  • Carbonylation
    • Time Frame: Immediately before treatment and 48 hours after therapy
    • Pro-oxidant status

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • American British Cowdray Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alfredo Aisa Alvarez, Principal Investigator – American British Cowdray Medical Center
  • Overall Official(s)
    • Alfredo Aisa Alvarez, MD, Principal Investigator, American British Cowdray Medical Center

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