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

NCT04756115 | Completed

• 1 other identifier: PNI-2016/19
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Peripheral Arterial Disease; Critical Limb Ischemia; Biomarkers; Prognostic Nutritional Index; Mortality Rate

Outcome Measures

Primary Outcomes (1)

• 6-month mortality

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

  6-month

Secondary Outcomes (1)

• 6-month major amputation

  6-month

Other Outcomes (1)

• Hospital length-of-stay

  Immediately after the surgery

Study Arms (1)

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.

Interventions

Vascular Surgery. PROCEDURE

Open Vascular, endovascular or hybrid procedures.

CASES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All patients diagnosed with a first episode of critical limb ischemia revascularized at our center from January 2016 to July 2019.

You may not qualify if:

• Patients with acute limb ischaemia.
• Patients with CLTI revascularized before 2016.
• Patients without serum albumin collected in the first 48 hours after admission.

Sponsors & Collaborators

• Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery: lead
• Hospital Clínico Universitario de Valladolid: collaborator

Study Sites (1)

Hospital Clínico Universitario de Valladolid

Valladolid, 47005, Spain

Location

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MeSH Terms

Conditions

Postoperative Complications; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Interventions

Vascular Surgical Procedures

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Ischemia

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 16, 2021
• Study Start: January 1, 2016
• Primary Completion: July 30, 2019
• Study Completion: July 31, 2019
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)