Epidemiology and prognostic utility of cellular components of hematological system in sepsis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AIIMS
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- measured at day one of sepsis and after 72 hours (initial value and change over 72 hours)
研究概览
简要总结
Primary objective: To identify if parameters derived from cellular components of hematological system (hematocrit, red cell distribution width, evidence of hemolysis in peripheral blood smear,thrombocytopenia, immature granulocytes, immature platelet fraction and platelet distribution width) measured on day 1 of sepsis and after 72 hrs (initial value and change over 72 hrs) can predict 28 day mortality in adult patients with sepsis admitted to ICU.
Hypothesis: A composite index derived from hematological system can improve the prognostic utility of SOFA score (Sequential organ failure assessment ) in sepsis patients.
Study protocol: Adult patients fulfilling inclusion criteria will be recruited to study in the 24 hrs of diagnosis of sepsis. Their blood samples will be sent to the hospitals’s hematology lab to evaluate the study parameters on day 1 and again after 72 hrs. All the patients will be followed up till hospital discharge or death ,whichever is earlier. After data compilation is complete, the entire study population will be divided into two groups based on 28 day hospital mortality : survivors and non survivors. The difference in the study parameters between these two groups will be calculated by applying appropriate statistical methods.
研究设计
- 研究类型
- Observational
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 Sepsis patients admitted in ICU 2 Within 24 hours of diagnosis of sepsis 3 Age 18-65 years.
排除标准
- •Patients’/ their relatives’ refusal to consent for study.
- •Preexisting hematological disorder/ malignancy.
- •Previous history of sepsis
- •History of ICU stay within last 6 months
- •Any chronic disease, which can impair hematological system
- •History of blood transfusion in the last two weeks before ICU admission or within first three days of ICU admission.
结局指标
主要结局
measured at day one of sepsis and after 72 hours (initial value and change over 72 hours)
时间窗: 28 days
To identify if parameters derived from cellular components of hematological system i.e.,
时间窗: 28 days
can predict 28-day mortality in adult patients with sepsis admitted to intensive care unit.
时间窗: 28 days
Hematocrit, red cell distribution width, evidence of hemolysis in peripheral blood smear, immature granulocytes,thrombocytopenia, immature platelet fraction and platelet distribution width,
时间窗: 28 days
次要结局
- Increased length of ICU stay,(Increased number of days on mechanical ventilation,)