NCT02106975已完成2 期
Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 5
- 主要终点
- C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo
研究概览
简要总结
Hypothesis 1A: Vitamin C infusion will significantly attenuate sepsis-induced systemic organ failure as measured by Sequential Organ Failure Assessment (SOFA) score,
Hypothesis 1B: Vitamin C infusion will attenuate sepsis-induced lung injury as assessed by the oxygenation index and the VE40
Hypothesis 1C: Vitamin C infusion will attenuate biomarkers of inflammation (C-Reactive Protein, Procalcitonin), vascular injury (Thrombomodulin, Angiopoietin-2), alveolar epithelial injury (Receptor for Advanced Glycation Products), while inducing the onset of a fibrinolytic state (Tissue Factor Pathway Inhibitor).
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
- •Patients must have suspected or proven infection, and meet 2 out of 4 of the criteria for Systemic Inflammatory Response (SIRS) due to infection, and be accompanied by at least 1 criterion for sepsis-induced organ dysfunction, and meet all 5 criteria for Acute Respiratory Distress Syndrome (ARDS).
- •Suspected or proven infection: (e.g., thorax, urinary tract, abdomen, skin, sinuses, central venous catheters, and central nervous system, see Appendix A).
- •The presence of a systemic inflammatory response: Defined as: fever: >38ºC (any route) or hypothermia: <36ºC (core temp only), tachycardia: heart rate > 90 beats/min or receiving medications that slow heart rate or paced rhythm, leukocytosis: >12,000 WBC/µL or leukopenia: <4,000 WBC/µL or >10% band forms. Respiratory rate > 20 breaths per minute or PaCO2 < 32 or invasive mechanical ventilation.
- •The presence of sepsis associated organ dysfunction: (any of the following thought to be due to infection)
- •Sepsis associated hypotension (systolic blood pressure (SBP) < 90 mm Hg or an SBP decrease > 40 mm Hg unexplained by other causes or use of vasopressors for blood pressure support (epinephrine, norepinephrine, dopamine =/> 5mcg, phenylephrine, vasopressin)
- •Arterial hypoxemia (PaO2/FiO2 < 300) or supplemental O2 > 6LPM.
- •Lactate > upper limits of normal laboratory results
- •Urine output < 0.5 ml/kg/hour for > two hours despite adequate fluid resuscitation
- •Platelet count < 100,000 per mcL
- •Coagulopathy (INR > 1.5)
- •Bilirubin > 2 mg/dL
- •Glasgow Coma Scale < 11 or a positive CAM ICU score
- •ARDS characterized by all the following criteria
- •Lung injury of acute onset, within 1 week of an apparent clinical insult and with progression of respiratory symptoms
- •Bilateral opacities on chest imaging not explained by other pulmonary pathology (e.g. pleural effusions, lung collapse, or nodules)
- •Respiratory failure not explained by heart failure or volume overload
- •Decreased arterial PaO2/FiO2 ratio ≤ 300 mm Hg
- •Minimum PEEP of 5 cmH2O (may be delivered noninvasively with CPAP to diagnose mild ARDS
排除标准
- •Known allergy to Vitamin C
- •inability to obtain consent;
- •age < 18 years;
- •No indwelling venous or arterial catheter in patients requiring insulin in a manner that requires glucose being checked more than twice daily (e.g. continuous infusion, sliding scale);
- •presence of diabetic ketoacidosis;
- •more than 48 hrs since meeting ARDS criteria;
- •patient or surrogate or physician not committed to full support (not excluded if patient would receive all supportive care except for cardiac resuscitation);
- •pregnancy or breast feeding,
- •moribund patient not expected to survive 24 hours;
- •home mechanical ventilation (via tracheotomy or noninvasive) except for CPAP/BIPAP used only for sleep-disordered breathing;
- •home O2 > 2LPM, except for with CPAP/BIPAP
- •diffuse alveolar hemorrhage (vasculitis);
- •interstitial lung disease requiring continuous home oxygen therapy;
- •Active kidney stone
- •Non English speaking;
- •Ward of the state (inmate, other)
研究组 & 干预措施
Ascorbic Acid
Active Comparator
200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours
干预措施: Ascorbic Acid (Drug)
结局指标
主要结局
C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo
时间窗: up to 168 hours
Modified Change in Sequential Organ Failure Assessment (mSOFA) Score
时间窗: 96 hours
mSOFA is a single score based on patient status of five different biological systems: respiratory, cardiovascular, coagulation, renal, and neurological. Scores range from 0 to 20 with higher scores indicated worse status.
Thrombomodulin Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo
时间窗: Up to 168 hours
次要结局
- mSOFA Scores at Hours 0, 48, 96(Up to hour 96)
- Receptor for Advanced Glycation Endpoints at Study Hour 0, 48, 96, 168(Up to hour 168)
- Oxygenation Score: Saturation(Up to hour 168)
- Coagulation(Up to hour 168)
- Procalcitonin at Study Hour 0, 48, 96, 168(Up to hour 168)
- Tissue Factor Pathway Inhibitor at Study Hour 0, 48, 96, 168(Up to hour 168)
- Ventilator Free Days to Day 28(Up to Day 28)
- All Cause Mortality to Day 28(Up to Day 28)
- Oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) at Study Hour 0, 48, 96, 168 if Still Intubated in Ascorbate Infused Patient Compared to Placebo.(Up to hour 168)
- VE-40 (Vent RR x TV/Weight) x (PaCO2/40) at Study Hour 0, 48, 96, 168 if Still Intubated, in Ascorbate Infused Patient Compared to Placebo(Up to hour 168)
- ICU-free Days at Day 28(Up to Day 28)
- Hospital-free Days at Day 60(Up to Day 60)
- Ascorbate Level at Hour 0, 48, 96, 168(Up to hour 168)
- Oxygenation Score: Pressure(Up to hour 168)
- Liver Function(Up to hour 168)
- Cardiovascular Function(Up to hour 168)
- State of Consciousness(Up to hour 168)
- Renal Function(Up to hour 168)
研究者
研究点 (5)
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