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

February 13, 2021 updated by: Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valladolid, Spain, 47005
        • Hospital Clinico Universitario de Valladolid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with a first episode of critical limb ischemia revascularized.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CASES
Adults (age<18 years) diagnosed with a first episode of critical limb ischemia revascularized at our center from January 2016 to July 2019.
Procedure: Vascular Surgery.
Open Vascular, endovascular or hybrid procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month mortality
Time Frame: 6-month
Correlation between pre-operative pro-inflammatory and nutritional biomarkers with mortality after vascular surgery.
6-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month major amputation
Time Frame: 6-month
Correlation between pre-operative pro-inflammatory and nutritional biomarkers with major amputation after vascular surgery.
6-month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

Collaborators

Hospital Clínico Universitario de Valladolid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

February 8, 2021

First Submitted That Met QC Criteria

February 13, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 13, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNI-2016/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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