Randomized Controlled Clinical Trial of Antioxidant Therapy in Critically Ill Patients With Septic Shock: Analysis Before and After Treatment of the Oxidative Stress
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Organic failure measurement by the Sequential Organ Failure Assessment Score (SOFA)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Melatonin
干预措施: Melatonin 5 mg (Drug)
Vitamin C
干预措施: Vitamin C 1 GM Oral Tablet (Drug)
Vitamin E
干预措施: Vitamin E 400 UNT (Drug)
N-acetylcysteine
干预措施: N-acetylcysteine (Drug)
结局指标
主要结局
Organic failure measurement by the Sequential Organ Failure Assessment Score (SOFA)
时间窗: 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.
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.
次要结局
- Nitrates and nitrites levels(Immediately before treatment and 48 hours after therapy)
- Malondialdehyde levels(Immediately before treatment and 48 hours after therapy)
- Glutathione Peroxidase Enzyme Activity(Immediately before treatment and 48 hours after therapy)
- Carbonylation(Immediately before treatment and 48 hours after therapy)
- Total antioxidant capacity(Immediately before treatment and 48 hours after therapy)
- Glutathione S-transferase Activity(Immediately before treatment and 48 hours after therapy)
- Extracellular Superoxide Dismutase Activity(Immediately before treatment and 48 hours after therapy)
- Glutathione concentration(Immediately before treatment and 48 hours after therapy)
- Selenium(Immediately before treatment and 48 hours after therapy)
- Vitamin C(Immediately before treatment and 48 hours after therapy)
- Thioredoxin(Immediately before treatment and 48 hours after therapy)
研究者
Alfredo Aisa Alvarez
Principal Investigator
American British Cowdray Medical Center