Association of the Systemic Immune-inflammation Index (SII) and Severity of Diabetic Ketoacidosis in Patients With Type 1 Diabetes Mellitus: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- SII
研究概览
简要总结
Diabetic ketoacidosis (DKA) is the most serious metabolic complication of type 1 diabetes mellitus (T1DM). Insulin deficiency and inflammation play a role in the pathogenesis of DKA. The investigators aim to assess the systemic immune-inflammation index (SII) as a marker of severity among T1DM patients with DKA and without infection.
详细描述
Diabetic ketoacidosis (DKA) is one of the most severe acute metabolic complications of diabetes mellitus (DM). Therefore, DKA patients require prompt treatment and any delay in identifying severe DKA cases can lead to worse outcomes. DKA provokes a systemic inflammatory response through increased levels of various cytokines such as interleukin (IL)-8, IL-6, IL-10, tumor necrosis factor-alpha (TNF-α), and IL-1B. This will lead to cellular activation, cellular adhesion, increased oxidative stress, and endothelial damage, possibly contributing to complications. Consequently, surrogate markers of inflammation and immune status may help in the early identification of patients with severe DKA.
The systemic immune-inflammation index (SII) had a better prognostic value compared to NLR and PLR among cancer patients. Recently, studies have suggested a link between SII and increased risk of atherosclerotic cardiovascular disease (ASCVD), hepatic steatosis, and worse outcomes among hypertensive patients and patients with stroke.
Therefore, the investigators aim to examine SII as a marker of severity in T1DM patients with DKA in an uninfected state.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of T1DM
- •Hospitalization because of DKA
- •Age ≥ 12 years.
排除标准
- •Diagnosis of T2DM
- •Diagnosis of Infection
- •Renal impairment
- •Malignancy
- •ASCVD (atherosclerotic cardiovascular disease)
- •History of any medical condition or medications that can change CBC parameters or cause metabolic acidosis
- •Pregnancy
结局指标
主要结局
SII
时间窗: Day 1 (baseline)
SII = (neutrophil × platelet) / lymphocyte.
次要结局
- ICU admission(Hospital stay up to one week)
- readmission(within 90 days)
研究者
Mohamed Aon
Principal Investigator
Jahra Hospital