- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02258698
Insulin Sensitivity, Irisin and Adipokines as Outcome Parameters in Patients Undergoing Cardiac Surgery
BACKGROUND: Surgical injury and inflammation provoke a stereotypical stress response. Insulin resistance plays an intriguing role in these metabolic alterations and depends on the intensity of injury. Metabolic derangements resulting from peripheral insulin resistance are unambiguously related to adverse outcomes and higher perioperative complication rates. Therefore, insulin resistance offers to act as a marker for stress and is potentially relevant in predicting clinical outcome. Plasma-glycosylated hemoglobin A (HbA1c) is an established indicator for blood glucose control and has a prognostic value regarding outcomes after major surgical interventions.
Adipose tissue holds a key function in endocrine metabolism by releasing multiple substances, so-called adipose-derived secreted factors or adipokines. Recent studies have linked several adipokines to overall insulin sensitivity in metabolic syndrome-related conditions as well as in critical illness. Irisin, a recently identified myokine acts on white adipose tissue and plays a role in the prevention of insulin resistance.
AIMS OF THE STUDY: The aim of this study is to assess the level and the effects of perioperative insulin resistance on clinical outcome in cardiac surgery patients. Based on previous studies suggesting glucose homeostasis and insulin resistance are associated with severity of illness and outcome in critically ill patients,it is proposed that patients with marked insulin resistance suffer from worse clinical outcome. This study protocol evaluates the ability of homeostasis model assessment (HOMA), quantitative insulin sensitivity check index (QUICKI), HbA1c, the adipokines Angiopoietin-like protein 2 (ANGPTL2), C-X-C motif chemokine 5 (CXCL5), and visfatin, and the myokine irisin to indicate perioperative insulin resistance and explores for correlation with adverse clinical outcomes after 30 days.
MATERIAL & METHODS: 325 patients admitted to the surgical intensive care unit after elective on-pump cardiac surgery will be consecutively enrolled. Baseline characteristics and routine blood samples will be assessed the day before surgery. Study blood samples will be drawn preoperatively in the induction bay of anesthesia to measure the insulin resistance indices HOMA and QUICKI, HbA1c, ANGPTL2, CXCL5, visfatin, and irisin. Blood glucose, irisin, adipokines, and routine biochemical tests will be assessed upon admission to the intensive care unit and on postoperative days 1 and 3. Adverse outcomes will be assessed 30 days after surgery. Sample size is set to ensure at least 80% power at a significance level of 0.05.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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BS
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Basel, BS, Suisse, 4031
- Andrea Kopp Lugli
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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:
- Aged >18 years
- Admission to the surgical intensive care unit after elective cardiac surgery (aortocoronary bypass and/or valve repair)
- Being capable of understanding and signing the consent form
Exclusion Criteria:
- Blood glucose values requiring continuous insulin infusion preoperatively
- Ongoing selenium therapy
- Pregnancy
- Interventional valve repair
- Intraoperative hypothermic cardiac arrest
- Off-pump cardiac surgery
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Elective on-pump cardiac surgery
Observation of perioperative Insulin resistance in patients undergoing elective on-pump cardiac surgery (CABG and/or valve repair)
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Blood samples for assessing Insulin resistance by HOMA, QUICKI, HbA1c, ANGPTL2, CXCL5, visfatin and irisin are drawn during induction of anesthesia, upon arrival on the intensive care unit and on postoperative day 1 and 3. Thirty days after surgery adverse outcomes covering all-cause morbidity and mortality will be assessed.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Number of adverse outcomes in relation to Insulin resistance measured as HOMA (homeostasis model assessment)
Délai: 30 days after surgery
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30 days after surgery
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Number of adverse outcomes in relation to Insulin resistance measured as QUICKI
Délai: 30 days after surgery
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30 days after surgery
|
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Number of adverse outcomes in relation to Insulin resistance measured as HbA1c
Délai: 30 days after surgery
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30 days after surgery
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Number of adverse outcomes in relation to Insulin resistance measured as ANGPTL2
Délai: 30 days after surgery
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30 days after surgery
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Number of adverse outcomes in relation to Insulin resistance measured as CXCL5
Délai: 30 days after surgery
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30 days after surgery
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Number of adverse outcomes in relation to Insulin resistance measured as NAMPT
Délai: 30 days after surgery
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30 days after surgery
|
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Number of adverse outcomes in relation to Insulin resistance measured as irisin
Délai: 30 days after surgery
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30 days after surgery
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Andrea Kopp Lugli, MD, MSc, University Hospital, Basel, Switzerland
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 56/13
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