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- Essai clinique NCT04756115
Impact of Nutritional and Inflammatory Status in Patients With Critical Limb-threatening Ischemia
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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Valladolid, Espagne, 47005
- Hospital Clínico Universitario de Valladolid
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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6-month mortality
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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6-month major amputation
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Hospital length-of-stay
Délai: 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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Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
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- Stabile E, Kinnaird T, la Sala A, Hanson SK, Watkins C, Campia U, Shou M, Zbinden S, Fuchs S, Kornfeld H, Epstein SE, Burnett MS. CD8+ T lymphocytes regulate the arteriogenic response to ischemia by infiltrating the site of collateral vessel development and recruiting CD4+ mononuclear cells through the expression of interleukin-16. Circulation. 2006 Jan 3;113(1):118-24. doi: 10.1161/CIRCULATIONAHA.105.576702. Epub 2005 Dec 27. Erratum In: Circulation. 2006 Apr 18;113(15):e711.
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- Gary T, Pichler M, Belaj K, Hafner F, Gerger A, Froehlich H, Eller P, Rief P, Hackl G, Pilger E, Brodmann M. Platelet-to-lymphocyte ratio: a novel marker for critical limb ischemia in peripheral arterial occlusive disease patients. PLoS One. 2013 Jul 2;8(7):e67688. doi: 10.1371/journal.pone.0067688. Print 2013.
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Première soumission répondant aux critères de contrôle qualité
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Termes liés à cette étude
Mots clés
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