Lipid derangement in sepsis and non-infective systematic inflammatory response syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare the lipid profile in patients with sepsis and non-infective Systemic inflammatory response syndrome patients like acute pancreatitis and early trauma.
研究概览
简要总结
This prospective observational study will be conducted over 1year (16th july 2025 to 15july 2026). After approval of the local ethical committee and obtaining informed written consent, all patients >16 years of age admitted to the intensivecare unitof a tertiary teaching hospital with suspicion of sepsis will be included in the study. The demographic characteristics (age, sex), initial vitals, initial lab investigations, diagnosis, The Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sepsis-related Organ Failure Assessment (SOFA) severity scores, and clinical data will be collected prospectively for each patient.
Serum lipid profile [triglyceride (TG), cholesterol, low-density lipoprotein (LDL), VLDL and high density lipoprotein (HDL)] measured by enzymatic method at admission and on day three will be recorded for each patient. ICU and in-hospital mortality at 30days, length of stay in the ICU and the hospital, renal replacement therapy and vasopressor use, and SOFA score at admission at 48 hours will be collected. The changes in lipid profile between sepsis and non infective SIRS; and correlation of lipid profile with severity off illness and mortality will be noted.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 16.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients more than 16 and less than 85 years of age admitted with SIRS in intensive care unit will be included within 24 hours of admission.
- •Sepsis will be defined based on Sepsis 3.0 definition and either clinically, radiologically or microbiological evidence of bacterial infection.
- •Non infective SIRS will be defined by Acute pancreatitis or trauma presenting within 48hrs of onset.
排除标准
- •1.Refusal to give consent 2.Patients on Lipid lowering drugs 3.Severe Malnourishment: BMI less than18 or more than30 4.Uncontrolled diabetes mellitus (HBA1c more than 8) • Known eating disorders.
- •• Known Metabolic Syndromes • Post operative patients Non specific causes of SIRS Non bacterial causes of infection like viral, fungal protozoal etc.
结局指标
主要结局
To compare the lipid profile in patients with sepsis and non-infective Systemic inflammatory response syndrome patients like acute pancreatitis and early trauma.
时间窗: Day 0 and 3
次要结局
- To assess the correlation between lipid profiles and 30-day mortality in patients with sepsis(Day 0 and 3)
- To assess the association of the lipid profile in sepsis with severity of illness using APACHE II and Sequential Organ Failure Assessment (SOFA) score.(day 0 and 3)
- To find the trend of the lipid profile over time (at admission and the 3rd day) in patients with sepsis admitted to the ICU.(Day 0 and 3)
研究者
Dr Ruchi Gupta
Holy Family Hospital