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临床试验/NCT04137276
NCT04137276已完成不适用

Effect of Intravenous Vitamin C on Sequential Organ Failure Assessment (SOFA) Score Among Septic Patients: Randomized Controlled Trial

Indonesia University1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2019年4月1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
入组人数
33
试验地点
1
主要终点
Sequential Organ Failure Assessment (SOFA) score

研究概览

简要总结

This study aimed to explore the effect of intravenous (IV) vitamin C on sequential organ failure assessment (SOFA) score among septic patients in intensive care unit (ICU).

详细描述

"This study was approved by the Ethics and Research Committee of Universitas Indonesia. This study was a randomized clinical trial held from April to July 2019 in Cipto Mangunkusumo Hospital. 33 patients that met the inclusion criteria were included in the study. Subjects were divided into two groups: group A (intervention group, n = 18) received parenteral infusions of 1,5 g/6 hours of vitamin C and 200 mg thiamine, while group B (control group, n = 15) received 200 mg thiamine only. baseline demographic data was recorded on the first day. SOFA score was recorded at baseline, 24 hours, 48 hours, and 72 hours after treatment. Data were analyzed using SPSS (Statistical Package for Social Sciences) software."

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • patients with sepsis diagnosis based on sepsis-3 criteria in the ICU in between 6 hours to 24 hours post resuscitation after sepsis diagnosis

排除标准

  • patients with chronic kidney problems on haemodialysis,
  • patients with kidney stones or kidney problem within the last 3 months

研究组 & 干预措施

vitamin C and thiamine

Experimental

patients who received intravenous vitamin C and thiamine

干预措施: vitamin C, vitamin B1 (Drug)

thiamine

Active Comparator

patients who received thiamine

干预措施: vitamin B1 (Drug)

结局指标

主要结局

Sequential Organ Failure Assessment (SOFA) score

时间窗: 3 months

Sequential Organ Failure Assessment (SOFA) score score measured at several specified times. higher score indicates higher mortality in septic patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adhrie Sugiarto

Staff Lecturer at Department of Anesthesiology and Intensive Care

Indonesia University

研究点 (1)

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