Clinical Trial of Antioxidant Therapy in Patients With Septic Shock

NCT ID: NCT03557229

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-23
• Study Completion Date: 2022-06-30

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.

Conditions

Oxidative Stress; Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Melatonin

Group Type: EXPERIMENTAL

Melatonin 5 mg

Intervention Type: DRUG

Oral: 50 mg once daily for 5 days

Vitamin C

Group Type: EXPERIMENTAL

Vitamin C 1 GM Oral Tablet

Intervention Type: DRUG

Oral: 1 GM every 6 hours for 5 days

Vitamin E

Group Type: EXPERIMENTAL

Vitamin E 400 UNT

Intervention Type: DRUG

Oral: 400 UNT every 8 hours for 5 days

N-acetylcysteine

Group Type: EXPERIMENTAL

N-acetylcysteine

Intervention Type: DRUG

Oral: 1200 mg every 12 hours for 5 days

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Melatonin 5 mg

Oral: 50 mg once daily for 5 days

Intervention Type: DRUG

Vitamin C 1 GM Oral Tablet

Oral: 1 GM every 6 hours for 5 days

Intervention Type: DRUG

Vitamin E 400 UNT

Oral: 400 UNT every 8 hours for 5 days

Intervention Type: DRUG

N-acetylcysteine

Oral: 1200 mg every 12 hours for 5 days

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American British Cowdray Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Alfredo Aisa Alvarez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alfredo Aisa Alvarez, MD

Role: PRINCIPAL_INVESTIGATOR

American British Cowdray Medical Center

Locations

Centro Médico ABC

Mexico City, , Mexico

Countries

Mexico

References

Aisa-Alvarez A, Perez-Torres I, Guarner-Lans V, Manzano-Pech L, Cruz-Soto R, Marquez-Velasco R, Casarez-Alvarado S, Franco-Granillo J, Nunez-Martinez ME, Soto ME. Randomized Clinical Trial of Antioxidant Therapy Patients with Septic Shock and Organ Dysfunction in the ICU: SOFA Score Reduction by Improvement of the Enzymatic and Non-Enzymatic Antioxidant System. Cells. 2023 May 6;12(9):1330. doi: 10.3390/cells12091330.

Reference Type: DERIVED

PMID: 37174730 (View on PubMed)

Other Identifiers

ABC-18-19

Identifier Type: -

Identifier Source: org_study_id