Evaluating Vitamin C in Septic Shock: A Randomized Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Number of Participants With ICU Mortality
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled clinical trial to compare Vitamin C versus placebo for patients presenting to the ICU with a diagnosis of septic shock.
详细描述
This is a multi-site, randomized, double-blind, placebo-controlled trial comparing a regimen of moderate-dose (6000 mg per day) Vitamin C supplementation versus placebo for the treatment of patients presenting to the ICU with septic shock. Both groups will continue to receive all other standard of care measures for septic shock as clinically indicated. Groups will be enrolled and receive study drug/placebo for 4 days (96 hours) or until 24 hours post-last pressor dose, whichever is sooner.
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
- •• Capability to provide written consent from participant or legally authorized representative (LAR) if the participant is unable or incapacitated due to severity of illness.
- •Age ≥ 18 years
- •Septic shock as pragmatically defined as:
- •o Order for intravenous antimicrobials with either procalcitonin > 2 mg/dL within 24 hours of enrollment OR other clinical suspicion of infection or confirmed infection AND
- •Hypotension requiring vasopressor therapy, despite fluid resuscitation of at least 30 cc/kg AND
- •Lactate > 2 mmol/L 24 hr prior to enrollment AND
- •Presence of sepsis defined as equal to or greater than 2 SIRS criteria and/or acute increase in qSOFA score of 2 points or more.
- •SIRS criteria: 1) Temperature greater than 38° or less than 36° Celsius. 2) Heart rate greater than 90 beats per minute. 3) Respiratory rate greater than 20 breaths per minute OR arterial carbon dioxide tension less than 32 mmHg. 4) White blood cell count greater than 12,000 cell/µL, less than 4,000 cells/µL, OR band cells greater than 10% of the total white blood cell population.
- •qSOFA: 1 point each is assigned for: 1) systolic blood pressure below 100, 2) respiratory rate greater than 22, and 3) mental status not at baseline.
排除标准
- •• Unable to start infusion within 24 hours of septic shock identification
- •Currently pregnant or breastfeeding
- •Patient to receive comfort measures only
- •Cardiac Arrest
- •Cardiovascular Surgery patients receiving prophylactic peri-operative antibiotics < 48 hours post-operation
- •Participation in another study involving an investigational product within 30 days of the baseline visit
- •Allergy to Vitamin C
- •History of nephrolithiasis
- •History of G6PD deficiency
- •ESRD patients, transplant eligible on dialysis currently taking vitamin C supplementation
- •Clinical course that treating clinician decides would preclude safe participation
研究组 & 干预措施
Placebo
Placebo designed to mimic intervention
干预措施: Placebo (Drug)
Intervention
6000 mg per day Vitamin C supplement
干预措施: Vitamin C (Drug)
结局指标
主要结局
Number of Participants With ICU Mortality
时间窗: 28 days
Outcome is reported as the number of patients who expired while receiving care in the intensive care unit (ICU).
All Cause Mortality at 28 Days
时间窗: 28 days
Outcome is reported as the number of participants who have expired at 28 days post intervention
次要结局
- Duration of ICU Stay Post Intervention Administration(28 days)
- Duration of Vasopressor Therapy(28 days)
- Change in Serum Creatinine(Baseline and 4 days)
- Rate of Lactate Clearance Post Intervention Administration(24, 48, 72, and 96 hours post intervention)
- Change in Sequential Organ Failure Assessment (SOFA) Score(Baseline and 4 days)
- Change in Acute Physiology and Chronic Health Evaluation (APACHE) Scores(Baseline and 4 days)
- Rate of Procalcitonin Clearance Post Intervention Administration(4 days)
- Time to Lactate Clearance Post Intervention Administration(28 days)
- Number of Participants With Need for Renal Replacement Therapy(4 days)
- Total Intravenous Fluid Administered(24 hours)