The Effect of Hydrocortisone-Ascorbic Acid and Thiamine Therapy on the Outcome of Patients With Sepsis: A Prospective Randomized Double-Blinded Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 28th day mortality rate.
研究概览
简要总结
In this study , we suggest that the use of combination of Hydrocortisone, Ascorbic Acid, and Thiamine in patient with sepsis may decrease mortality rate and improve the outcome.
This study will be carried out at SICU of Tanta University hospitals on Patients aged from 18 to 65 years old who will be presented with sepsis that diagnosed according to the surviving sepsis campaign 2016.
Patients who will meet the previous criteria will be enrolled in the study. The patients will be randomized allocated into two groups by the aid of computer generated software of randomization introduced into sealed closed envelops.
All patients will receive the conventional therapy according to the surviving sepsis campaign 2016 and The Surviving Sepsis Campaign Bundle 2018 Update.
The patients will be allocated randomly into one of the following two groups;-. Group I The patients in this group will be managed only according to the surviving sepsis campaign 2016 and the surviving sepsis campaign bundle 2018 update.
The patients will receive 50 ml normal saline I.V within 30 mins / 6 h, 10 ml normal saline I.V / 6 h, 5 ml normal saline I.V / 12 h.
Group II The patients will receive the conventional therapy of sepsis and combined therapy of hydrocortisone (Solucortif® 100 mg , vial, dried powder Pfizer, Egypt) 50 mg diluted in 5 ml normal saline IV / 6 h, ascorbic acid (VITAMIN C-®, Amp, ROTEXMEDICA, Germany, 500mg/5ml) 1.5 gm diluted in 50 ml normal saline IV within 30 min /6 h , and thiamine (Vitamin B1-injektopas®, Ampoule, Germany, 100 mg / 2 ml) 200 mg diluted in 10 ml normal saline IV /12 h The outcome of the patients, the incidence of organ dysfunction will be assessed.
详细描述
This prospective randomized controlled double-blinded study will be carried out at surgical intensive care units (SICU) in Tanta University Hospitals for a period of 12 months that may be extended after approval from institutional ethical committee.
An informed written consent will be obtained from the patients or patients' relatives.
They will receive an explanation of the purpose of the study and every patient will have a secret code number.
Research results will be only used for scientific purpose. Any unexpected risk/s appearing during the course of research will be clarified to the participants and to the ethical committee on time, however, the patients that will be enrolled in this study have no expected additional risk as we use Hydrocortisone, Ascorbic acid and Thiamin that have minimal side effects.
*Inclusion criteria: Patients aged from 18 to 65 years old who will be presented with sepsis that diagnosed according to the surviving sepsis campaign 2016(21) and The Surviving Sepsis Campaign Bundle 2018 Update.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
All data will be collected by intensivists who will be blinded about the study groups.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 18 to 65 years old who will be presented with sepsis that diagnosed according to the surviving sepsis campaign 2016 and The Surviving Sepsis Campaign Bundle 2018 Update
排除标准
- •Participant or participants' relatives refusal to continue the study.
- •Known or suspected allergy to the studied medications.
- •Contraindications to the use of vitamin C as renal stones, Alzheimer's disease and Schizophrenia.
- •Pre-existing organ failure or dysfunction not related to the presenting sepsis condition.
- •Pregnancy.
研究组 & 干预措施
Group I
The patients in this group will be managed only according to the surviving sepsis campaign 2016 and the surviving sepsis campaign bundle 2018 update.
The patients will receive 50 ml normal saline I.V within 30 mins / 6 h, 10 ml normal saline I.V / 6 h, 5 ml normal saline I.V / 12 h.
干预措施: Normal saline (Drug)
Group II
The patients will receive the conventional therapy of sepsis and combined therapy of hydrocortisone (Solucortif® 100 mg , vial, dried powder Pfizer, Egypt) 50 mg diluted in 5 ml normal saline IV / 6 h, ascorbic acid (VITAMIN C-®, Amp, ROTEXMEDICA, Germany, 500mg/5ml) 1.5 gm diluted in 50 ml normal saline IV within 30 min /6 h , and thiamine (Vitamin B1-injektopas®, Ampoule, Germany, 100 mg / 2 ml) 200 mg diluted in 10 ml normal saline IV /12 h This combined therapy will be given for 4 days or to the time of discharge if the admission period is less than 4 days
干预措施: Hydrocortisone, Ascorbic acid, Thiamine (Drug)
结局指标
主要结局
28th day mortality rate.
时间窗: 28 days
The incidence of mortality in the first 28 days
次要结局
- Changes in SOFA score(28 days)
- Changes in serum pocalcitonin level(7 days)
研究者
Sameh Abdelkhalik Ahmed Ismaiel
Dr
Tanta University