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临床试验/CTRI/2024/03/063852
CTRI/2024/03/063852已完成2/3 期

To compare efficacy of high dose Vitamin C infusion and Thiamine (vitamin B1) infusion in patients of sepsis.

Uttar Pradesh University of medical sciences saifai etawah1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年3月18日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
To compare the SOFA (Sequential Organ Failure Assessment) score.

研究概览

简要总结

Sepsis is known as the main cause of death in critically ill patients and is responsible for one-third to half of the hospital mortalities. Sepsis is caused by an infectious organism, especially Gram-positive infections, which triggers a local immune response. The migration of neutrophils into the inflamed tissue will follow causing a release of free radicals and inflammatory mediators which may trigger, in some patients, a systemic inflammatory response syndrome (SIRS). SIRS may progress to severe sepsis, septic shock, and multiple organ dysfunction syndrome (MODS. Supplementation of vitamin C and thiamine in patients with sepsis remains an attractive therapeutic target, considering the potential benefits, low costs and favourable safety profile. Aim of the study is to compare the efficacy of vitamin c infusion with thiamine (vitamin B1) infusion in patients of sepsis.

This is a  prospective randomized double blind clinical study. Study will be conducted on 75 patient with sepsis admitted in intensive care unit . Patient will be randomized in 3 group 25 in each group. One group will receive injection vitamin C, one group will receive injection Thiamine and one group will receive placebo. Outcome  data will be analysed in terms of efficacy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with body mass index between 18 to 30 2.Patient who will not be on mechanical ventilator but fulfilling the criteria of sepsis at the time of inclusion for study 3.Patient who will be on standard treatment with similar antibiotics 4.Patient with SOFA score more than 2 but less than 8 will be included in the study.

排除标准

  • 1.Pregnant or breastfeeding females 2.Moribund and not expected to survive 96 hours 3.Cancer as the cause of sepsis 4.Patients with chronic kidney disease, chronic alcoholics and immuno-compromised patients.

结局指标

主要结局

To compare the SOFA (Sequential Organ Failure Assessment) score.

时间窗: 6 days

次要结局

  • 1. Incidence of ventilator associated pneumonia (VAP) if patient requires(mechanical ventilation after inclusion in study.)

研究者

发起方
Uttar Pradesh University of medical sciences saifai etawah
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sonali Agrawal

Upums saifai etawah

研究点 (1)

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