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

NCT04756115 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 310

Last updated 2021-02-16

No results posted yet for this study

Summary

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.

Conditions

  • Critical Lower Limb Ischemia
  • Postoperative Complications

Interventions

PROCEDURE

Vascular Surgery.

Open Vascular, endovascular or hybrid procedures.

Sponsors & Collaborators

  • Hospital Clínico Universitario de Valladolid

    collaborator OTHER

  • Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

    lead NETWORK

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2019-07-30
Completion
2019-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04756115 on ClinicalTrials.gov