Impact of Nutritional and Inflammatory Status in Patients With Critical Limb-threatening Ischemia
13. februar 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
310
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Valladolid, Spanien, 47005
- Hospital Clinico Universitario de Valladolid
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients diagnosed with a first episode of critical limb ischemia revascularized.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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6-month mortality
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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6-month major amputation
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Hospital length-of-stay
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2016
Primær færdiggørelse (Faktiske)
30. juli 2019
Studieafslutning (Faktiske)
31. juli 2019
Datoer for studieregistrering
Først indsendt
8. februar 2021
Først indsendt, der opfyldte QC-kriterier
13. februar 2021
Først opslået (Faktiske)
16. februar 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. februar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. februar 2021
Sidst verificeret
1. februar 2021
Mere information
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Nøgleord
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Andre undersøgelses-id-numre
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Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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