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临床试验/CTRI/2021/09/036902
CTRI/2021/09/036902尚未招募不适用

Comparison of SOFA score and serum procalcitonin combination with SOFA score alone in predicting short-term mortality in patients with sepsis

ABVIMS and Dr RML hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年1月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
160
试验地点
1
主要终点
Short term mortality or 28 day mortality in patients with sepsis

研究概览

简要总结

Sepsis continues to be a major public health problem globally. The worldwide burden of sepsis isdifficult to ascertain although a recently published article indicates that there were an estimated 48·9million incident cases of sepsis and 11·0 million sepsis-related deaths in 2017 representing 19·7% ofdeaths that year. These estimates are more than double of previous global figures, which is probablydue to addition of data from low-income and middle-income countries, locations where the incidenceof sepsis and associated mortality are significantly higher and for which data were previously unknown.Prevalence of sepsis-related mortality varies considerably according to location. Significant regionaldisparities in sepsis incidence and mortality exist; approximately 85.0% of sepsis cases and sepsis related deaths worldwide occurred in low- and middle-income countries. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3), defines sepsisas a life-threatening organ dysfunction caused by dysregulated host response to infection. Earlyidentification and diagnosis are essential, as prompt and appropriate treatment can improve survivaloutcomes. Despite advances in antibiotic therapy and modern life support, the fatality rate of patientswith sepsis has remained as high as 30%-50% worldwide. Early identification of patients at high riskof dying from sepsis may help initiate rapid and appropriate therapeutic interventions and may have agreat impact on sepsis-related morbidity and mortality. However, an accurate assessment of patients atrisk for poor clinical outcomes is challenging for clinicians.Clinical severity scores, such as the Sequential Organ Failure Assessment (SOFA) score, have beenvalidated for risk stratification in critical care settings. However, in recent years, a number of bloodbiomarkers have been identified that may provide additional information to estimate diseaseprogression in sepsis. Procalcitonin (PCT), the pre-hormone of calcitonin, has been widely investigatedin infectious diseases. Apart from its diagnostic value, an elevated PCT concentrations was reported tobe strongly associated with all-cause mortality in septic patients. The purpose of this study is tocompare SOFA score and serum procalcitonin combination with SOFA score alone in predicting shortterm mortality i.e 28-day mortality in patients with sepsis.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients aged more than equal to 18 years Patients with diagnosis of Sepsis and or Septic shock Patients with ICU stay of at least 24 hours.

排除标准

  • Refusal of Consent Pregnant and lactating females Patients who later turn out to be non sepsis Acute non infectious inflammatory conditions like burns, acute pancreatitis, massive trauma Patients with chronic kidney disease Stage IV and V Patients on immunosuppressive medications Patients with terminal cancer Patients with thyroid cancer any stage.

结局指标

主要结局

Short term mortality or 28 day mortality in patients with sepsis

时间窗: From admission into ICU till 28th day thereafter

次要结局

  • Microbial culture result(Duration of mechanical ventilation and or non-invasive ventilation)

研究者

发起方
ABVIMS and Dr RML hospital
申办方类型
Government medical college

研究点 (1)

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