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Effects of Vitamin C Administration on Extravascular Lung Water in Patients With Severe Features of Preeclampsia

2019年6月27日 更新者:Miha Lucovnik、University Medical Centre Ljubljana

Effects of Vitamin C Administration on Extravascular Lung Water in Patients With Severe Features of Preeclampsia: a Randomized, Placebo-controlled Trial

The objective of the study is to determine whether administration of vitamin C (1.5g/6 hours) in the first three days post-partum reduces the amount of extravascular lung water assessed by lung ultrasound in patients with severe preeclampsia.

研究概览

详细说明

Risk of fluid over-resuscitation is high in preeclampsia due to endothelial dysfunction and resulting increased vascular permeability. The Confidential Enquiry into Maternal Deaths in the UK reported six maternal deaths between 1994 and 1996 due to adult respiratory distress syndrome (ARDS) that appeared to be related to poor fluid management in women with preeclampsia. On the basis of these reported deaths, recommendations on limiting intravenous fluids to not more than to 80 ml/hour (or 1 ml/kg/h) have been made. Nevertheless, preeclampsia remains the leading cause of pulmonary edema in the peripartum period. Moreover, in some preeclamptic patients higher rates of intravenous fluid administration may be necessary to adequately correct tissue hypoperfusion.

Zieleskiewicz et al. were the first to demonstrate that lung ultrasound (LUS) can be used to objectively evaluate increased extravascular lung water (EVLW) in patients with preeclampsia. Ambrozic et al. recently confirmed these results and showed that the amount of EVLW assessed by LUS is increased in preeclamptic patients compared to healthy controls and that it decreases rapidly in the first four days following delivery.

It has been reported that administration of high-dose ascorbic acid (vitamin C) reduces vascular permeability in animals. In 2000, Tanaka et al. reported an RCT involving 37 patients with major burns (>30% body surface area) randomized regarding whether or not to receive an infusion of IV vitamin C, 66 mg/kg/h for the first 24 hours of hospitalization. Patients in the vitamin C group required less fluid resuscitation, had higher urine output, and developed less wound edema. This translated into improved oxygenation and less time on mechanical ventilation among the vitamin C group (average of 12 vs. 21 days of ventilation, p=0.03). In 2002, Nathens et al. randomized patients shortly after admission to a surgical ICU to no therapy vs. a combination of enteral vitamin E plus IV vitamin C 1000 mg/8h until ICU discharge. The primary endpoint was a composite of pneumonia or ARDS. Although there were trends towards fewer pulmonary complications among patients treated with antioxidants, these did not reach statistical significance (the study was underpowered due to low rates of respiratory complications). However, patients treated with vitamins E and C fared better on a variety of secondary endpoints including less time on the ventilator and less multiorgan failure.

In women with established preeclampsia, there is evidence of oxidative stress and decreased concentrations of vitamin C. An initial RCT on prophylactic supplementation with oral antioxidants, including 1g vitamin C daily, showed a significant reduction in preeclampsia (8 percent vs. 17 percent) in high-risk pregnancies. Subsequent large RCTs have, however, reported no significant reduction in the risks of preeclampsia, intrauterine growth restriction, or the risk of death or other serious outcomes in infants associated with oral vitamin C supplementation.There are no studies to date on use of higher dose IV vitamin C administration for reduction of capillary leak and consequently EVLW in patients with severe forms of preeclampsia. Given the safety (see below) and low costs of vitamin C this could be a promising approach to increase fluid tolerance in these patients. If vitamin C reduces vascular permeability in preeclampsia patients to the same degree that it seems to reduce vascular permeability in other conditions, such as burns, it could reduce the risk of pulmonary complications associated with this disease. At the same time, vitamin C therapy could allow safe additional fluid administration in patients with preeclampsia who are fluid responsive and in whom further increases in preload would be beneficial for preventing end-organ damage such as pre-renal acute kidney injury.

Safety of vitamin C

Safety of vitamin C has been well established even at high doses. For example, none of the above studies reported any adverse event, despite the use of very high doses by Tanaka et al. (1.6 grams/kg over 24 hours). One potential concern regarding vitamin C is that it may be metabolized into oxalic acid, leading to calcium oxalate nephropathy. This doesn't seem to be a significant problem for several reasons:

  • Oxalate formation is a dose-dependent toxicity. This has rarely been reported from short courses of IV vitamin C, but only at much higher doses (>40 grams/day).
  • In 2014, Fowler et al. published a phase I safety trial of vitamin C in patients with severe sepsis. Their prospective RCT involved patients with severe sepsis in a medical ICU. 24 patients were randomized to receive placebo, low-dose vitamin C (12.5 mg/kg IV/6hr), or high-dose vitamin C (50 mg/kg IV/6hr). The primary endpoint was safety and tolerability, with no adverse events noted.
  • Recently Marik et al. published a before-after study investigating the impact of treating sepsis with a combination of thiamine 200 mg IV/12hr, Vitamin C 1.5 g/6hr, and hydrocortisone 50 mg IV/6hr. Mortality was substantially reduced in patients receiving vitamin C (p<0.001). Moreover, vitamin C use correlated with improved renal outcomes (the rate of dialysis was reduced from 33% to 10%, p=0.02).

Another concern which has been raised is that vitamin C at extremely high doses may have a pro-oxidant effect. This was shown not to occur even at a dose of 7.5 grams IV daily.

研究类型

介入性

注册 (实际的)

34

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 50年 (成人)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

Singleton pregnancy with severe featutes of preeclampsia (any of the following):

  • Systolic blood pressure of 160 mm Hg or higher, or diastolic blood pressure of 110 mm Hg or higher on two occasions at least 4 hours apart while the patient is on bed rest (unless antihypertensive therapy is initiated before this time)
  • Thrombocytopenia (platelet count less than 100x109/L)
  • Impaired liver function as indicated by abnormally elevated blood concentrations of liver enzymes (to twice normal concentration), severe persistent right upper quadrant or epigastric pain unresponsive to medication and not accounted for by alternative diagnoses, or both
  • Progressive renal insufficiency (serum creatinine concentration greater 97 µmol/L or a doubling of the serum creatinine concentration in the absence of other renal disease)
  • Pulmonary edema
  • New-onset cerebral or visual disturbances

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:Vitamin C
1,5g of IV vitamin C in 100 ml 0.9% NaCl within 30 min of delivery and then every 6 hours for the first 72 hours post-partum (vitamin C arm).
1,5g of IV vitamin C in 100 ml 0.9% NaCl within 30 min of delivery and then every 6 hours for the first 72 hours post-partum.
安慰剂比较:placebo
100 ml of IV 0.9% NaCl within 30 min of delivery and then every 6 hours for the first 72 hours post-partum (placebo arm).
100 ml of IV 0.9% NaCl within 30 min of delivery and then every 6 hours for the first 72 hours post-partum.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Echo Comet Score at day 1 post-delivery
大体时间:Echo Comet Score (ECS) will be assessed by lung ultrasound at day 1 following delivery
The primary outcome studied will be the Echo Comet Score (ECS) at day 1 following delivery in the vitamin C vs. placebo group. ECS will be obtained by the 28-rib interspaces technique dividing the chest wall in 12 areas on the left (from the second to the fourth intercostal space) and 16 areas on the right (from the second to the fifth intercostal space) anterior and lateral hemithorax. The sum of ultrasonographic B-lines found on each scanning site (from 0 to 10) will yield a score ranging from 0 to 280. ECS denotes the amount of extravascular fluid in the lung, i.e. the higher the ESC, the larger the amount of extravascular lung water.
Echo Comet Score (ECS) will be assessed by lung ultrasound at day 1 following delivery

次要结果测量

结果测量
措施说明
大体时间
Echo Comet Score at day 2 post-delivery
大体时间:Echo Comet Score (ECS) will be assessed by lung ultrasound at day 2 following delivery
One of the secondary outcomes studied will be the Echo Comet Score (ECS) at day 2 following delivery in the vitamin C vs. placebo group. ECS will be obtained by the 28-rib interspaces technique dividing the chest wall in 12 areas on the left (from the second to the fourth intercostal space) and 16 areas on the right (from the second to the fifth intercostal space) anterior and lateral hemithorax. The sum of ultrasonographic B-lines found on each scanning site (from 0 to 10) will yield a score ranging from 0 to 280. ECS denotes the amount of extravascular fluid in the lung, i.e. the higher the ESC, the larger the amount of extravascular lung water.
Echo Comet Score (ECS) will be assessed by lung ultrasound at day 2 following delivery
Echo Comet Score at day 3 post-delivery
大体时间:Echo Comet Score (ECS) will be assessed by lung ultrasound at day 3 following delivery
One of the secondary outcomes studied will be the Echo Comet Score (ECS) at day 3 following delivery in the vitamin C vs. placebo group. ECS will be obtained by the 28-rib interspaces technique dividing the chest wall in 12 areas on the left (from the second to the fourth intercostal space) and 16 areas on the right (from the second to the fifth intercostal space) anterior and lateral hemithorax. The sum of ultrasonographic B-lines found on each scanning site (from 0 to 10) will yield a score ranging from 0 to 280. ECS denotes the amount of extravascular fluid in the lung, i.e. the higher the ESC, the larger the amount of extravascular lung water.
Echo Comet Score (ECS) will be assessed by lung ultrasound at day 3 following delivery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年4月7日

初级完成 (实际的)

2019年6月25日

研究完成 (实际的)

2019年6月27日

研究注册日期

首次提交

2018年2月17日

首先提交符合 QC 标准的

2018年2月23日

首次发布 (实际的)

2018年3月1日

研究记录更新

最后更新发布 (实际的)

2019年6月28日

上次提交的符合 QC 标准的更新

2019年6月27日

最后验证

2019年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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Vitamin C的临床试验

3
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