drugset / Trial / NCT03557229

Clinical Trial of Antioxidant Therapy in Patients With Septic Shock

NCT03557229

Phase 3 Unknown 131 enrolled American British Cowdray Medical Center
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 50 mg Oral
Subject N-acetylcysteine Small molecule 1200 mg Oral
Subject Vitamin C Other / unclassified 1 g Oral
Subject Vitamin E Other / unclassified 400 unknown Oral