Clinical Trial of Antioxidant Therapy in Patients With Septic Shock

American British Cowdray Medical Center131 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

131

Conditions

Oxidative Stress Septic Shock

Interventions

Melatonin 5 mgDRUG

Oral: 50 mg once daily for 5 days

Vitamin C 1 GM Oral TabletDRUG

Oral: 1 GM every 6 hours for 5 days

Vitamin E 400 UNTDRUG

Oral: 400 UNT every 8 hours for 5 days

N-acetylcysteineDRUG

Oral: 1200 mg every 12 hours for 5 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Centro Médico ABC

Mexico City, Mexico

Outcomes

Primary Outcomes

Organic failure measurement by the Sequential Organ Failure Assessment Score (SOFA)

The SOFA score is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The worst physiological variables is collected serially every 24 hours of a patient's ICU admission. The "worst" measurement is defined as the measure that correlated to the highest number of points. The SOFA score ranges from 0 to 24. The investigators are going to evaluate the daily total score and the trend before and after the administration of the therapy.

Time frame: Up to 7 days (1 week). From date of randomization and every 24 hours until discharge from the intensive care unit or date of death from any cause, whichever came first, assessed up to 7 days.