Impact of Nutritional and Inflammatory Status in Patients With Critical Limb-threatening Ischemia
Impact of Nutritional and Inflammatory Status in Patients With Critical Limb-threatening Ischemia: a Retrospective Cohort Stud
The peripheral arterial disease (PAD) has been associated with all-cause and cardiovascular mortality. Despite minimally invasive endovascular techniques, patients with critical limb-threatening ischemia (CLTI) have a poor prognosis with a high mortality that is comparable that of cancer.
The inflammatory activity has a crucial role for the development and prognosis of atherosclerosis. Recently, different inflammatory biomarkers such as the neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR) and lymphocyte to monocyte ratio (LMR) have been associated with severity and prognosis in patients with PAD.
Additionally, patients with CLTI present several independent risk factors for malnutrition. For this reason, malnutrition represents an independent risk factor for mortality and post-operative complications. In this context, the Prognostic Nutritional Index (PNI) associates the nutritional and inflammatory status of patients.
This study shows the clinical applicability of the different pre-operative nutritional and inflammatory biomarkers in patients with CLTI. This study does not collect any patient identifiable information.
研究概览
详细说明
In order to show the relevance of patient's inflammatory status regarding the prognosis of PAD, this study establishes the correlation between pre-operative pro-inflammatory biomarkers represented by NLR, LMR and PLR with short-term mortality and major amputations at 6-months. Likewise, the association between the pre-operative PNI with short-term mortality and major amputation at 6-months revealing the impact of nutritional status.
- Data Collection: Demographic and clinical data. The initial surgical technique. The peri-operative outcomes Mortality and major amputation. The hemogram and biochemistry analysis were recorded preoperatively, at 48-hours after admission The inflammatory state was measured by the ratios of neutrophil/lymphocyte (NLR), lymphocyte/monocyte (LMR) and platelet/lymphocyte (PLR).
The nutritional status was estimated by the PNI = (serum albumin g/dL x 10) + (lymphocytes/μL + 0.005).
- Statistical Analysis: significant values p<0.05. Descriptive analysis was presented as mean values and respective standard deviations.
The chi-squared test and Student t-test were used for variables that followed a normal distribution.
A non-parametric test was performed for the rest of variables (Mann-Whitney U). Spearman and Pearson correlations coefficients were calculated to determine the association between biomarkers and the hospital length-of-stay.
For the multivariate analysis a logistic regression was performed. A receiver operating characteristic (ROC) curve analysis was applied to establish a cut-off point with the corresponding area under the curve (AUC), 95% confidence interval (95%CI), sensitivity (S) and specificity (E) for short-term mortality and major amputation at six months.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Valladolid、西班牙、47005
- Hospital Clínico Universitario de Valladolid
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- All patients diagnosed with a first episode of critical limb ischemia revascularized at our center from January 2016 to July 2019.
Exclusion Criteria:
- Patients with acute limb ischaemia.
- Patients with CLTI revascularized before 2016.
- Patients without serum albumin collected in the first 48 hours after admission.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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CASES
Adults (age<18 years) diagnosed with a first episode of critical limb ischemia revascularized at our center from January 2016 to July 2019.
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Open Vascular, endovascular or hybrid procedures.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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6-month mortality
大体时间:6-month
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Correlation between pre-operative pro-inflammatory and nutritional biomarkers with mortality after vascular surgery.
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6-month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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6-month major amputation
大体时间:6-month
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Correlation between pre-operative pro-inflammatory and nutritional biomarkers with major amputation after vascular surgery.
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6-month
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Hospital length-of-stay
大体时间:Immediately after the surgery
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Correlation between pre-operative pro-inflammatory and nutritional biomarkers with hospital length-of-stay after vascular surgery.
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Immediately after the surgery
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合作者和调查者
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Vascular Surgery.的临床试验
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Fogarty Clinical Research Inc.Abbott Medical Devices; Helen Kay Foundation; Northern Michigan Hospital Foundation's Louis A....未知
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St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences Organization完全的
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Seoul National University HospitalJohnson & Johnson Medical Companies完全的