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Clinical Trial of Antioxidant Therapy in Patients With Septic Shock

NCT03557229 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2021-08-10

No results posted yet for this 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.

Conditions

  • Oxidative Stress
  • Septic Shock

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

Sponsors & Collaborators

  • American British Cowdray Medical Center

    lead OTHER

Principal Investigators

  • Alfredo Aisa Alvarez, MD · American British Cowdray Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-23
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03557229 on ClinicalTrials.gov