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临床试验/NCT04710329
NCT04710329已完成不适用

High-Dose Vitamin C Treatment in Critically Ill COVID-19 Patients, A Retrospective Cohort Study

Sisli Hamidiye Etfal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2021年1月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
1
主要终点
short term mortality

研究概览

简要总结

Acute respiratory failure due to COVİD-19 pneumonia has poor prognosis and high mortality . Both the lack of an effective antiviral treatment and the low level evidence of the recommendations presented in the guidelines on other treatment methods have highlighted supportive treatments. Studies suggest that high-dose vitamin C treatment reduces mortality in patients with sepsis and ARDS, and may also be beneficial in COVİD-19 disease. In the study; the investigator aimed to determine the effect of Vitamin C on short-term mortality and length of intensive care stay in COVID-19 patients.

详细描述

SARS-CoV-2 causes tissue damage in the endothelium and epithelium, increased vascular permeability and increased plasma levels of IL-6, IL-2, IL-7, IL-10 causing interstitial fibrosis in the lung is considered. Considering these factors in pathogenesis, a picture with high mortality from acute respiratory failure to severe ARDS emerges in critically ill COVID-19 patients. However, despite numerous studies, an effective antiviral treatment has not yet been found in COVID-19 disease. The low level of evidence for the recommendations presented in the guidelines on both treatment and mechanical ventilation has brought supportive treatments to the agenda. Recently, many articles have been published on the potential effects of anti-inflammatory and antioxidant treatments such as high-dose vitamin C, vitamin D, zinc and ozone therapy. In particular, high-dose intravenous vitamin C treatment is inexpensive, easily accessible, and it reduces mortality in patients with sepsis and ARDS in studies, suggesting that it may be beneficial in COVID-19 disease. this is a retrospective cohort study. The main goal of the study; to compare patients who did not receive high-dose vitamin C treatment in the first period of the epidemic and those who received treatment in the next period. the investigator aimed to determine the effect of Vitamin C on short-term mortality and length of stay in intensive care in critically ill COVID-19 patients. All patients' data on age, gender, body mass index, comorbidities (diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, other), PaO2 / FiO2 ratios, SOFA scores, ferritin, C-Reactive Protein, procalcitonin, lactate, neutrophil and lymphocyte values will be collected by scanning the hospital information system.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized with diagnosis of COVID-19, diagnosis confirmed by PCR test
  • pneumonia due to COVID-19 was diagnosed with clinical and radiological findings
  • Patients who developed acute respiratory failure (PaO2 / FiO2 300 despite the use of 6 l / min reservoir mask) caused by COVID-19 pneumonia
  • Older than 18 year

排除标准

  • Renal failure
  • Hepatic failure
  • End-stage malignity
  • Primary lung disease (lung cancer, cardio-pulmonary edema)
  • Patients who treated with tocilizumab
  • Presence of diabetic ketoacidosis, use of insulin infusion, or frequent need for point-of-care glucose monitoring (>6 times/24 hour period) as determined by treating physician
  • Active kidney stone
  • patients with hospitalization in ICU less than 96 hours

研究组 & 干预措施

C Vit

The patients who were admitted to the intensive care unit and received a high dose intravenous vitamin C protocol constituted the treatment group

干预措施: Ascorbic acid (Drug)

non-C Vit

The patients who were admitted to the intensive care unit but did not receive the vitamin C protocol constituted the control group

干预措施: Ascorbic acid (Drug)

结局指标

主要结局

short term mortality

时间窗: days 1-28

Incidence of mortality at 28 days by all causes

Length of Intensive Care Unit Stay

时间窗: up to 28 days

Length of Intensive Care Unit Stay

次要结局

  • PaO2/FiO2 ratio(1-4 day)
  • C-reactive protein(1-4 days)
  • ferritin(1-4 days)
  • SOFA(1-4 days)
  • vasopressor requirement(1-28 days)
  • invasive mechanical ventilation requirement(1-28 days)
  • procalcitonin(1-4 days)
  • Lymphocyte count(1-4 days)

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

nurcan coskun

specialist medical doctor

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (1)

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