A Prospective, Randomized Clinical Study Comparing Triple Therapy Regimen to Hydrocortisone Monotherapy in Reducing Mortality in Septic Shock Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- The number of patients who died within 28 days.
研究概览
简要总结
this study is conducted to evaluate the role of the novel triple therapy combination in reducing the mortality rate, reducing the shock time, and reversal of organ damage.
the study includes two arms, the first arm is the control which received hydrocortisone monotherapy and the second arm is the intervention arm which received the triple therapy regimen.
calculation of 28 days in-hospital mortality is the primary outcome. shock time, vasopressor doses, infection markers, and organ function tests are the secondary outcomes.
the data will be analyzed by student t-test or Mann Whitney test, Fischer exact or chi-square test for numbers, repeated measures ANOVA will be used to consider confounders and other parameters, mortality will be expressed by Kaplan Meier and ROC curve.
For Multivariate analysis of repeated quantitative outcomes, linear mixed models were used to quantify the relationship between one dependent variable (SOFA, SCr, doses of vasopressors) and many independent variables including group type and sepsis phenotype adjusted to other clinical and demographic factors.
详细描述
Background:
"Sepsis" is a life-threatening organ dysfunction caused by the dysregulated host response to infection. Septic Shock: Subset of sepsis with circulatory and cellular/metabolic dysfunction associated with a higher risk of mortality. Organ dysfunction can be identified by acute change in the total Sequential Organ Failure Assessment (SOFA) score of 2 points or higher consequent to the infection.
Septic shock patients can be identified by developing sepsis with persistent arterial hypotension requiring vasopressors to keep mean arterial pressure (MAP) above 65 mm Hg and having serum lactate above 2 mmol/L. In hospitals, the mortality of septic shock according to retrospective studies is around 35%-54%. Pneumonia is the most common site of infection (about 50%) of cases, followed by intra-abdominal infection and urinary tract infection.
The (1-hr Bundle) is the cornerstone of the management, it encourages clinicians to act as quickly as possible to obtain blood cultures, administer broad-spectrum antibiotics, start appropriate fluid resuscitation, measure lactate, and begin vasopressors if clinically indicated. Ideally, these interventions would all begin in the first hour from sepsis recognition but may not necessarily be completed in the first hour. However, over the last few years, there have been interesting investigational novel therapeutic approaches. One of them is the use of high dose vitamin C. A small retrospective study demonstrated a mortality benefit by using high dose vitamin C, thiamine (vitamin B1), and hydrocortisone (Triple therapy) for treatment of septic shock in the adult population.
The normal plasma vitamin C level is ≥ 23 µmol/l. A recent study found that 88% of septic shock patients have hypovitaminosis C (<23 µmol/l), while 38% have a scurvy level (<11 µmol/l). The acute deficiency of vitamin C in this category of patients may be caused by the increased metabolic consumption due to critical illness such (trauma, burn, septic shock, etc.).
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
- 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
- 否
入选标准
- •Age >18 years.
- •Diagnosis of septic shock has been established (need vasopressors to maintain MAP ≥ 65, lactate ≥ 2mmol/L and SOFA score ≥2) [25,26].
排除标准
- •Pregnancy and lactation.
- •Refusal of attending staff or patient family.
- •Contraindication to any of the components of the triple therapy regimen such as (hypersensitivity to vitamin C and Patients with G6PD deficiency).
- •Patients on immunosuppressive medications and oncology patients. Do not resuscitate/do not intubate (DNR, DNI) patients
研究组 & 干预措施
Hydrocortisone Monotherapy
Hydrocortisone Monotherapy
干预措施: vitamin c - thiamine- hydrocortisone (Drug)
triple therapy regimen (vitamin c - thiamine- hydrocortisone)
triple therapy regimen (vitamin c - thiamine- hydrocortisone)
干预措施: vitamin c - thiamine- hydrocortisone (Drug)
结局指标
主要结局
The number of patients who died within 28 days.
时间窗: 28 days
patients were followed up daily for 28 days, this is the number of patients who died within 28 days.
ICU Mortality
时间窗: Within 28 days
The number of patients who died during ICU stay
次要结局
- the number of days that are needed to off the patients from vasopressors.(28 Days)
- the number of days that are needed to off the patients from mechanical ventilation.(28 days)
- Change in organ's functions test such as (serum creatinine, Alanine Aminotransferase (ALT)(28 days)