Clinical trial NCT03557229: Clinical Trial of Antioxidant Therapy in Patients With Septic Shock
Official title: Randomized Controlled Clinical Trial of Antioxidant Therapy in Critically Ill Patients With Septic Shock: Analysis Before and After Treatment of the Oxidative Stress
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Oxidative Stress
Septic Shock
Keywords: Oxidative Stress
Sepsis
Treatment
Antioxidant therapy
Lead sponsor: American British Cowdray Medical Center
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Organic failure measurement by the Sequential Organ Failure Assessment Score (SOFA)
timeFrame: 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.
Secondary outcomes:
measure: Nitrates and nitrites levels
timeFrame: Immediately before treatment and 48 hours after therapy
measure: Malondialdehyde levels
timeFrame: Immediately before treatment and 48 hours after therapy
measure: Total antioxidant capacity
timeFrame: Immediately before treatment and 48 hours after therapy
measure: Glutathione Peroxidase Enzyme Activity
timeFrame: Immediately before treatment and 48 hours after therapy
measure: Glutathione S-transferase Activity
timeFrame: Immediately before treatment and 48 hours after therapy
measure: Extracellular Superoxide Dismutase Activity
timeFrame: Immediately before treatment and 48 hours after therapy
measure: Glutathione concentration
timeFrame: Immediately before treatment and 48 hours after therapy
measure: Selenium
timeFrame: Immediately before treatment and 48 hours after therapy
measure: Vitamin C
timeFrame: Immediately before treatment and 48 hours after therapy
measure: Thioredoxin
timeFrame: Immediately before treatment and 48 hours after therapy
measure: Carbonylation
timeFrame: Immediately before treatment and 48 hours after therapy
Other outcomes:
measure: TNF-α
timeFrame: Immediately before treatment and 48 hours after therapy
measure: IL-1
timeFrame: Immediately before treatment and 48 hours after therapy
measure: IL-6
timeFrame: Immediately before treatment and 48 hours after therapy
measure: Ionized Ca2+
timeFrame: Immediately before treatment and 48 hours after therapy
measure: Ionized Mg2+
timeFrame: Immediately before treatment and 48 hours after therapy
Locations:
city: Mexico City
country: Mexico
facility: Centro Médico ABC
Study officials:
affiliation: American British Cowdray Medical Center
name: Alfredo Aisa Alvarez, MD
role: PRINCIPAL_INVESTIGATOR
References: