Clinical Trial of Antioxidant Therapy in Patients With Septic Shock

American British Cowdray Medical Center

Status and phase: Unknown; Phase 3

Conditions: Oxidative Stress; Septic Shock

Treatments: Drug: N-acetylcysteine; Drug: Vitamin E 400 UNT; Drug: Melatonin 5 mg; Drug: Vitamin C 1 GM Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03557229

ABC-18-19

Details and patient eligibility

About

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.

Enrollment: 131 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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131 participants in 5 patient groups

Melatonin

Experimental group

Treatment:

Drug: Melatonin 5 mg

Vitamin C

Experimental group

Treatment:

Drug: Vitamin C 1 GM Oral Tablet

Vitamin E

Experimental group

Treatment:

Drug: Vitamin E 400 UNT

N-acetylcysteine

Experimental group

Treatment:

Drug: N-acetylcysteine

Control

No Intervention group