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NCT Number: NCT04756115

Impact of Nutritional and Inflammatory Status in Patients With Critical Limb-threatening Ischemia

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.

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Key information

Conditions

Critical Lower Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Postoperative Complications Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico Universitario de Valladolid

Valladolid, 47005, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vascular Surgery.

Procedure

Open Vascular, endovascular or hybrid procedures.

Primary outcomes

  1. 6-month mortality

    Time frame: 6-month

    Correlation between pre-operative pro-inflammatory and nutritional biomarkers with mortality after vascular surgery.

Secondary outcomes

  1. 6-month major amputation

    Time frame: 6-month

    Correlation between pre-operative pro-inflammatory and nutritional biomarkers with major amputation after vascular surgery.

Other outcomes

  1. Hospital length-of-stay

    Time frame: Immediately after the surgery

    Correlation between pre-operative pro-inflammatory and nutritional biomarkers with hospital length-of-stay after vascular surgery.

Sponsors and collaborators

Lead sponsor

Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

Network

Collaborators

  • Hospital Clínico Universitario de Valladolid

Registry information

Official study title

Impact of Nutritional and Inflammatory Status in Patients With Critical Limb-threatening Ischemia: a Retrospective Cohort Stud

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 16, 2021
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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