NCT03557229

Clinical Trial of Antioxidant Therapy in Patients With Septic Shock

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 131 (estimated)
• Sponsor: American British Cowdray Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-07-23
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2018-06-14
• Last updated: 2021-08-10

Locations

1 site across 1 country: Mexico