Clinical Trial of Antioxidant Therapy in Patients With Septic Shock

Last updated: August 3, 2021
Sponsor: American British Cowdray Medical Center
Overall Status: Active - Not Recruiting

Phase

3

Condition

Sepsis And Septicemia

Stress

Low Blood Pressure (Hypotension)

Treatment

N/A

Clinical Study ID

NCT03557229
ABC-18-19
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of septic shock in the last 24 hours characterized by refractory hypotensionand vasopressor requirement despite sufficient fluid resuscitation (20 mL/kg ofcolloids or 40 mL/kg of crystalloids) to maintain a blood pressure ≥ 65 mmHg with alactate> 2 mmol/L.
  • Admitted to the ICU of the ABC Medical Center.
  • Give informed consent.

Exclusion

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 ormelatonin.
  • Pregnant women.

Study Design

Total Participants: 131
Study Start date:
July 23, 2018
Estimated Completion Date:
June 30, 2022

Connect with a study center

  • Centro Médico ABC

    Mexico City, 05300
    Mexico

    Site Not Available

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