The Impact of Albumin Infusion Targets on Mortality in Patients With Abdominal Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- 28-day mortality
研究概览
简要总结
Hypoalbuminemia has been shown to be significantly associated with increased mortality from abdominal sepsis, and early albumin infusion to maintain high serum albumin concentrations may be beneficial for the recovery of patients with abdominal sepsis. However, there have been no reports on whether administering albumin infusion can improve the prognosis, and there is no unified standard for the optimal serum albumin level for exogenous albumin infusion. This study aims to retrospectively collect patients with abdominal sepsis from 2017 to 2022, and divide them into three groups based on their serum albumin levels on the first day of admission to the ICU (D1): high albumin group (HA): albumin level>35g/L, medium albumin group (MA): albumin level between 30-35g/L, low albumin group (LA): albumin level<30g/L, to explore the relationship between different albumin levels and 28 day mortality rate, as well as the corresponding time point fluid balance The effects of vasoactive drug dosage and organ function, mechanical ventilation time, AKI incidence and renal function outcomes, CRRT usage rate, and hospital stay.
详细描述
Research Background Introduction to Sepsis and Abdominal Sepsis Sepsis is a life-threatening condition characterized by organ dysfunction due to a dysregulated immune response to infection. Abdominal sepsis, originating from intra-abdominal infections, is particularly challenging due to its high morbidity and mortality rates. The mortality rate for abdominal sepsis ranges from 7.6% to 36.0%, and it can reach up to 50% if it progresses to septic shock. The presence of hypoalbuminemia further complicates the clinical course and prognosis of sepsis patients.
Role of Albumin in Sepsis Albumin is a major plasma protein with several critical functions, including maintaining oncotic pressure, transporting various substances, and modulating the immune response. Hypoalbuminemia, defined as serum albumin levels below 30 g/L, is commonly observed in critically ill patients and is associated with increased mortality and morbidity. In sepsis, hypoalbuminemia may result from increased vascular permeability, decreased synthesis, or increased catabolism of albumin. Previous studies have suggested that hypoalbuminemia is an independent risk factor for mortality in abdominal sepsis. However, the specific impact of hypoalbuminemia on mortality in patients with abdominal sepsis remains underexplored.
Objective of the Study Given the high mortality rates associated with abdominal sepsis and the potential impact of hypoalbuminemia on patient outcomes, this study aims to investigate the association between baseline serum albumin levels and 28-day mortality in patients with abdominal sepsis complicated by hypoalbuminemia. The study also explores the specific level of albumin at which mortality is most affected.
Methods Study Design This study was conducted as a retrospective cohort study in a comprehensive ICU with 79 beds at Nanfang Hospital of Southern Medical University. The study was granted exemption from informed consent by the Ethics Committee due to its retrospective nature and was approved under protocol number NFEC-2023-470. The study complied with the Declaration of Helsinki, and all patient data were anonymized to ensure privacy.
Study Population The study included patients aged ≥18 years with abdominal sepsis admitted to the Department of Critical Care Medicine from September 2017 to February 2022. The inclusion criteria were: intra-abdominal infection, sepsis/septic shock, hypoalbuminemia (plasma albumin level <30 g/L upon admission), and infusion of human albumin within 24 hours of ICU admission. Exclusion criteria included: no hospitalization record, readmission to the ICU, ICU stay <24 hours, and conditions requiring albumin therapy (e.g., cirrhosis with ascites, post-liver transplantation, nephrotic syndrome).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to the Intensive Care Department of Southern Hospital of Southern Medical University from September 2017 to June 2022;
- •Age ≥ 18 years old;
- •Meeting the diagnostic criteria for abdominal infection;
- •Patients who meet the diagnostic criteria for sepsis/septic shock;
- •Complicated with hypoalbuminemia, i.e. plasma albumin<30g/L after admission;
- •Human serum albumin injection was infused within 24 hours after check-in into the ICU.
排除标准
- •Pregnant or lactating women
- •Patients who have not been able to obtain relevant diagnosis and treatment information after ICU check-in
- •Patients who repeatedly stay in the ICU
- •ICU hospitalization time is less than 24 hours
- •Pathological conditions that require albumin treatment in clinical practice (cirrhosis with ascites, post liver transplantation, intestinal malabsorption syndrome, nephrotic syndrome, burns);
研究组 & 干预措施
HA
serum albumin level was above 35g/L after albumin infusion within 72 hours of ICU admission for intra-abdominal sepsis patients
干预措施: Human serum albumin injection (Drug)
MA
serum albumin level was between 30 and 35g/L after albumin infusion within 72 hours of ICU admission for intra-abdominal sepsis patients.
干预措施: Human serum albumin injection (Drug)
LA
serum albumin level was less than 30g/L after albumin infusion within 72 hours of ICU admission for intra-abdominal sepsis patients.
干预措施: Human serum albumin injection (Drug)
结局指标
主要结局
28-day mortality
时间窗: up to 28 days
Follow-up on the mortality status of patients within 28 days after ICU admission.
次要结局
- norepinephrine equalent doses(up to 72 hours after ICU admission)
- Fliuid balance(up to 72 hours after ICU admission)
- Indicators of kidney(up to 72 hours after ICU admission)
- Indicators of liver(up to 72 hours after ICU admission)
- Mechanical ventilation time(up to 28 days)
- Indicators of lungs(up to 72 hours after ICU admission)
- total hospitalization time(up to 1 year)
- ICU hospitalization time(up to 1 year)