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临床试验/NCT02734147
NCT02734147终止2 期

The Efficacy of Intravenous Ascorbic Acid in Patients With Severe Sepsis

Christiana Care Health Services1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
24
试验地点
1
主要终点
Change in Modified SOFA Score

研究概览

简要总结

Despite an organized treatment approach outlined in expert-consensus guidelines for sepsis with fluid resuscitation to treat hypovolemia, antibiotics to target the infectious insult, and vasopressors for hypotension, mortality rates for sepsis remain high and the incidence continues to rise, making sepsis the most expensive inpatient disease.

  1. Recent research has described the therapeutic benefits associated with ascorbic acid treatment for sepsis.
  2. Researchers objectives are to perform a randomized-controlled clinical trial investigating the ability of ascorbic acid(vitamin C) administration to decrease organ dysfunction in severe sepsis. The widespread occurrence of microvascular dysfunction in sepsis leading to tissue hypoxia, mitochondrial dysfunction, and adenosine triphosphate (ATP) depletion, gives rise to organ failure.
  3. Patients with organ failure and sepsis (severe sepsis) are at a higher risk of death than patients with organ failure alone. Critically ill patients may have an increased requirement for ascorbic acid in sepsis and these patients frequently have levels below normal. Ascorbic acid administration, has been shown to correlate inversely with organ failure (human literature) and directly with survival (animal studies).

4,5 Intravenous ascorbic acid therapy decreases organ failure by providing a protective effect on several microvascular functions including improving capillary blood flow, decreasing microvascular permeability, and improving arteriolar responsiveness to vasoconstrictors. Defining the utility of novel agents to augment researchers care for severe sepsis is an important task as investigators continue the institutional focus on sepsis care.

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

入选标准

  • Patients with:
  • A suspected or confirmed infection with an order for intravenous antibiotics or antivirals
  • The presence of acute sepsis-induced organ dysfunction
  • Definition of organ dysfunction:
  • Arterial hypoxemia [PaO2 /FiO2 < 300]
  • Hypotension [systolic blood pressure (SBP) < 90 mmHg or SBP decrease > 40 mmHg]
  • Lactic acidosis [lactate > 2.5 mmol/L]
  • Acute kidney injury [creatinine >2.0 or urine output < 0.5 ml/kg/hr for >2 hours despite fluid resuscitation]
  • Thrombocytopenia [platelet count < 100,000]
  • Acute coagulopathy [international normalized ratio (INR) > 1.5]
  • Hepatic failure [bilirubin > 2 mg/dL].
  • Predisposition, Infection, Response, and Organ Failure (PIRO) score ≥ 10

排除标准

  • Age < 18 years
  • Pregnancy or breastfeeding
  • Requirement for immediate surgery within the treatment protocol timeframe
  • Inability to obtain written informed consent from subject or surrogate
  • Patient to receive comfort measures only

研究组 & 干预措施

High dose IV ascorbic acid

Active Comparator

Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.

干预措施: Ascorbic Acid (Drug)

Placebo

Placebo Comparator

The placebo group will receive 100 ml 0.9% NaCl over 30 minutes every 8 hours for 72 hours.

干预措施: Normal Saline (Other)

结局指标

主要结局

Change in Modified SOFA Score

时间窗: Baseline and 72 hours

Sequential Organ Failure Assessment (SOFA) Score included the degree of dysfunction of six organ systems (Respiratory, Cardiovascular, Liver, Renal, Coagulation, Neurologic. A modification of the SOFA includes the exclusion of the Liver function. Total score is reported, minimum score = 0 maximum score = 20. Higher scores indicate greater degree of dysfunction.

次要结局

  • Modified SOFA Score(at 72 Hours)
  • ICU Length of Stay(Length of ICU stay up to 200 hours)
  • Hospital Length of Stay(From ICU admission through ICU discharge, up to 2 weeks)
  • Change in PIRO Score(Baseline and 72 hours)
  • Percentage of Participants Who Died(From initial hospital admission through discharge, up to 2 weeks.)
  • Ascorbic Acid Concentration at 32 Hours(32 Hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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