Clinical Trial of Antioxidant Therapy in Patients With Septic Shock

Septic Shock Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03557229
• Other study ID #: ABC-18-19
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 23, 2018
• Est. completion date: June 2022

Study information

• Verified date: August 2021
• Source: American British Cowdray Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 131
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oxidative Stress
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Melatonin 5 mg
Oral: 50 mg once daily for 5 days
• Vitamin C 1 GM Oral Tablet
Oral: 1 GM every 6 hours for 5 days
• Vitamin E 400 UNT
Oral: 400 UNT every 8 hours for 5 days
• N-acetylcysteine
Oral: 1200 mg every 12 hours for 5 days

Locations

Country	Name	City	State
Mexico	Centro Médico ABC	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
American British Cowdray Medical Center

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TNF-a	Inflammatory Response Pathway	Immediately before treatment and 48 hours after therapy
Other	IL-1	Inflammatory Response Pathway	Immediately before treatment and 48 hours after therapy
Other	IL-6	Inflammatory Response Pathway	Immediately before treatment and 48 hours after therapy
Other	Ionized Ca2+	Electrolytes	Immediately before treatment and 48 hours after therapy
Other	Ionized Mg2+	Electrolytes	Immediately before treatment and 48 hours after therapy
Primary	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.	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	Nitrates and nitrites levels	Oxidative stress	Immediately before treatment and 48 hours after therapy
Secondary	Malondialdehyde levels	Lipid peroxidation	Immediately before treatment and 48 hours after therapy
Secondary	Total antioxidant capacity	Antioxidant status	Immediately before treatment and 48 hours after therapy
Secondary	Glutathione Peroxidase Enzyme Activity	Antioxidant status	Immediately before treatment and 48 hours after therapy
Secondary	Glutathione S-transferase Activity	Antioxidant status	Immediately before treatment and 48 hours after therapy
Secondary	Extracellular Superoxide Dismutase Activity	Antioxidant status	Immediately before treatment and 48 hours after therapy
Secondary	Glutathione concentration	Antioxidant status	Immediately before treatment and 48 hours after therapy
Secondary	Selenium	Antioxidant status	Immediately before treatment and 48 hours after therapy
Secondary	Vitamin C	Antioxidant status	Immediately before treatment and 48 hours after therapy
Secondary	Thioredoxin	Antioxidant status	Immediately before treatment and 48 hours after therapy
Secondary	Carbonylation	Pro-oxidant status	Immediately before treatment and 48 hours after therapy