Saving Lives by Early Detection and Treatment of Sepsis and Septic Shock by Point of Care Lactate Test in Adults
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in serum lactate level after completion of hydration in the presence of clinical features of severe sepsis and shock
研究概览
简要总结
Burden:
The global burden of sepsis is difficult to ascertain, although a recent scientific publication estimated that in 2017 there were 48.9 million cases and 11 million sepsis-related deaths worldwide, which accounted for almost 20% of all global deaths. Recent chart analysis from Dhaka Hospital, icddrb recorded 350 adults with severe sepsis admitted over four years. Among them, 69% of patients progressed to septic shock.
Knowledge gap:
Clinical features of shock due to sepsis and shock due to severe dehydration are very intertwining and often predicament for critical care physicians. If not recognized early and managed promptly, it can lead to septic shock, multiple organ failure, and eventually death. Serum lactate may play a role as the point of care test in differentiating shock due to severe sepsis from shock due to severe dehydration.
Relevance:
Being the largest diarrhoeal disease hospital, the Dhaka Hospital of icddr,b is ideal for researching shock with diarrheal diseases. Even though the onset of sepsis can be acute and poses a short-term mortality burden, it can also cause significant long-term morbidity, requiring treatment and support. Thus, addressing sepsis and severe sepsis by early detection and prompt management should be a comprehensive way to reduce the burden in our community.
详细描述
The global burden of sepsis is difficult to ascertain, although a recent scientific publication estimated that in 2017 there were 48.9 million cases and 11 million sepsis-related deaths worldwide, which accounted for almost 20% of all global deaths. Recent chart analysis from Dhaka Hospital recorded 350 adults with severe sepsis admitted to a diarrheal hospital over four years, among them, 69% of patients progressed to septic shock.
If not recognized early and managed promptly, it can lead to septic shock, multiple organ failure, and death. It is most frequently a serious complication of infection, particularly in low- and middle-income countries. Early diagnosis and timely and appropriate clinical management of sepsis, such as optimal antimicrobial use and fluid resuscitation, are crucial to increase the likelihood of survival. Even though the onset of sepsis can be acute and poses a short-term mortality burden, it can also be the cause of significant long-term morbidity requiring treatment and support. Thus, sepsis requires a multidisciplinary approach.
Shock may occur as a ramification of severe sepsis, and on the other hand, a patient may present with shock due to severe dehydration from severe diarrhea. However, the differentiation of shock as a cascade of severe sepsis from the shock due to severe dehydration is intriguing. Fluid management in these two entities is different, although the initial bolus (30 ml/kg) in both cases is the same. If fluid management could not be done efficiently, some patients might end up with fluid overload especially in case of shock due to severe sepsis and under hydration in case of shock due to severe dehydration. On the other hand, there could be also overuse of inotropes if we are unable to identify the requirement of additional fluid. Thus, we need to have a point of care biomarker that may guide us further fluid requirement (or requirement of inotrope) after the initial bolus. Not only is severe sepsis the most common non-cardiac cause for intensive care unit (ICU) use, it has emerged as a major driver of hospital costs in developing countries.
Serum lactate level, which measures the level of lactic acid in the blood, is a fairly reliable and accurate indication of tissue hypoperfusion and hypoxia. The signs and symptoms, which may vary from patient to patient, include altered mental status; pale, cool, clammy skin; nausea and vomiting; diaphoresis; hypotension; tachypnea; and tachycardia. Surprisingly all these features are evident in severe sepsis or severe dehydration. In addition, septic shock is often associated with macrocirculatory dysfunction causing arterial hypotension, microcirculatory dysfunction, and decreased oxygen and nutrient extraction by peripheral tissues. Thus, lactic acid levels have become a useful marker for tissue hypoperfusion and may also serve as an endpoint for resuscitation in patients with sepsis and septic shock.
Serum lactate is proven to be an ideal point of care test to diagnose severe sepsis or septic shock successfully. On the other hand, although there is very limited knowledge regarding the utility of serum lactate in severe dehydration, evidence showed a reduction of serum lactate level after successful hydration.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients have shock due to severe sepsis or septic shock.
- •Consent to participate in the study from the patient or his accompanying caregiver.
排除标准
- •Any emergency which might require urgent referral within half an hour of admission.
- •Known case of cancer or chemotherapy.
- •Life-threatening conditions required cardiopulmonary resuscitation (CPR) on arrival.
- •Cardiac shock or anaphylactic origin
结局指标
主要结局
Change in serum lactate level after completion of hydration in the presence of clinical features of severe sepsis and shock
时间窗: Within 90 minutes of enrollment
First sample (POC-1): Lactate level on enrolment Second sample (POC-2): Lactate level after fluid bolus Expected outcome: Change in level of POC Lactate will be significant in those who do not require inotropes compared to those who require inotropes.
次要结局
- Requirement of multiple inotropes(Within 6 hours of enrollment)
