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临床试验/NCT03756727
NCT03756727Unknown早期 1 期

Effect of Perioperative Application of Ascorbic Acid on Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery

Xuzhou Medical University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
发起方
入组人数
110
试验地点
1
主要终点
severity of postoperative pulmonary complications

研究概览

简要总结

Postoperative pulmonary complications(PPCs) including, but not limited to ,hypoxemia, pneumonia, ventilator-induced lung injury, and acute respiratory distress syndrome (ARDS),atelectasis,pleural effusion .PPCs may result in increased resources utilization, delayed mobilization, prolonged need of supplemental oxygen or mechanical ventilation,and a longer hospital stay.postoperative pulmonary complications are common after cardiac surgery, often increasing postoperative morbidity and mortality.The extracorporeal circulation,increased oxygen concentration inhaled and the development of massive atelectasis after open-chest surgery commonly activate lung inflammation, amplifying the harm Injury of pulmonary .Currently, plenty of interventions have been studied to prevent PPCs after surgery. Most of the recent research has focused on physical therapy such as lung-protective modes during intraoperative mechanical ventilation, Alveolar Recruitment, and respiratory muscle training.These therapies have a certain effect, but still not satisfactory.Ascorbic acid is an important cofactor in multiple enzymatic reactions where its main function is as a reducing agent.Studies have shown that ascorbic acid can reduce both ischemia-reperfusion injury and oxidative stress. Unfortunately, no studies examined whether Ascorbic acid can reduce PPCs.

详细描述

The possible mechanisms of ascorbic acid to alleviate ischemia-reperfusion injury are as follows: 1 Ascorbic acid as a first-line antioxidant in plasma can reduce stress by eliminating excess Reactive oxygen species and reduce damage. 2 provides rapid electron transfer to react with superoxide and hydroxyl group to scavenge reactive oxygen released into the circulation. 3 Ascorbic acid can reduce lipid peroxidation and reduce lung injury caused by ischemia-reperfusion by scavenging oxygen free radicals. 4 Vitamin C can promote the production of cytokines by immune cells to reduce local inflammatory reactions and improve tissue microcirculation.The study aims to explore whether daily used Ascorbic acid in the perioperative period has a preventive effect on PPCs in patients undergoing cardiac surgery, and through short-term and long-term follow-up, to investigate the effect on post-hospitalization Prognosis .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18-60 years old
  • Selective cardiac surgery under cardiopulmonary bypass

排除标准

  • Emergency surgery
  • Previous cardiac surgery
  • Severe lung disease
  • BMI<18 or >30
  • Mean pulmonary arterial pressure >40 mmHg
  • were allergic to ascorbic acid

研究组 & 干预措施

Ascorbic acid group

Experimental

the patients received 2g of intravenous Ascorbic acid at the night before surgery, during the surgery and five days after surgery.

干预措施: Ascorbic Acid (Drug)

Control comparator group

Placebo Comparator

the patients received 10ml saline at the night before surgery, during the surgery and five days after surgery.

干预措施: Saline (Drug)

结局指标

主要结局

severity of postoperative pulmonary complications

时间窗: an average of 2 weeks

Use the postoperative pulmonary complications score to record the severity. scored ranging from 0 to 5.Scored the severity once a day, record the highest score.

次要结局

  • incidence of postoperative pulmonary complications(an average of 10 days)
  • extubation and wake time(an average of 1 day)
  • length of ICU stay and length of hospital stay(an average of 10 days)
  • PaO2/FiO2(1 day, 3 days,5 days post surgery)
  • A-aDO2(1 day, 3 days,5 days post surgery)
  • positive end expiratory pressure(an average of 1 day)
  • Plateau pressure(an average of 1 day)
  • Peak airway pressure(an average of 1 day)
  • post-hospitalization follow-up(once a day till 30 days post-hospitalization)
  • lung compliance(an average of 1 day)

研究者

发起方
Xuzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin Dong Liu

Principal Investigator

Xuzhou Medical University

研究点 (1)

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