Perioperative Metabolic and Hormonal Aspects in Major Emergency Surgery (PHASE)
21 janvier 2020 mis à jour par: Zealand University Hospital
Emergency laparotomies, which most often is performed due to high risk disease (bowel obstruction, ischemia, perforation, etc.), make up 11 % of surgical procedures in emergency surgical departments, however, give rise to 80 % of all postoperative complications. The 30-day mortality rates in relation to these emergent procedures have been reported between 14-30 %, with even higher numbers for frail and older patients. The specific reasons for these outcomes are not yet known, however, a combination of preexisting comorbidities, acute illness, sepsis, and the surgical stress response that arise during- and after the surgical procedure due to the activation of the immunological and humoral system, is most likely to blame. The complex endocrinological response and consequences of this response to emergency surgery are sparsely reported in the literature.
The aim of this PHASE project is to evaluate and describe the temporal endocrine, endothelial and immunological changes after major emergency abdominal surgery, and to associate these changes with clinical postoperative outcomes.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Réel)
98
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Køge, Danemark, 2300
- Department of Surgery, Zealand University Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Patients ≥ 18 years old undergoing acute major gastrointestinal surgery within 72 hours of their admission to the Department of Surgery or an acute reoperation.
Major gastrointestinal surgery are defined as procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction.
Patients will be consecutively screened for inclusion.
La description
Inclusion Criteria:
- Surgery within 72 hours of an acute admission to the Department of Surgery or an acute reoperation.
- Major gastrointestinal surgery on the gastrointestinal tract (see intervention definition)
Exclusion Criteria:
- Not capable of giving informed consent after oral and written information
- Previously included in the trial
- Elective laparoscopy
- Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (NB, if no procedure is performed because of inoperable pathology, then include)
- Appendectomy +/- drainage or Cholecystectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract
- Non-elective hernia repair without bowel resection.
- Minor abdominal wound dehiscence unless this causes bowel complications requiring resection
- Ruptured ectopic pregnancy, or pelvic abscesses due to pelvic inflammatory disease
- Laparotomy/laparoscopy for pathology caused by blunt or penetrating trauma, esophageal pathology, pathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes of immunological biomarkers
Délai: Change from preoperative levels at postoperative day 5
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Assessment of:
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Change from preoperative levels at postoperative day 5
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Number of patients with stress induced hyperglycemia
Délai: Postoperative day 5
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Assessment of:
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Postoperative day 5
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Changes of plasma thyroid hormones
Délai: Change from preoperative levels at postoperative day 5
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Assessment of:
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Change from preoperative levels at postoperative day 5
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Changes of the central endocrine stress response
Délai: Change from preoperative levels at postoperative day 5
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Assessment of plasma corticotropin releasing hormone (CRH)
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Change from preoperative levels at postoperative day 5
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Changes of sE-selectin
Délai: Change from preoperative levels at postoperative day 5
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Assessment of plasma sE-selectine
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Change from preoperative levels at postoperative day 5
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Changes of the endothelial function
Délai: Change from postoperative day 1 at postoperative day 5
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Assessed with the non-invasive EndoPAT and expressed as the reactive hyperemia index
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Change from postoperative day 1 at postoperative day 5
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Changes of the periferal endocrine stress response
Délai: Change from preoperative levels at postoperative day 5
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Assessment of plasma adrenocorticotropic hormone (ACTH)
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Change from preoperative levels at postoperative day 5
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Changes of cortisol
Délai: Change from preoperative levels at postoperative day 5
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Assessment of plasma cortisol (free and bound)
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Change from preoperative levels at postoperative day 5
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Changes of neuropeptides
Délai: Change from preoperative levels at postoperative day 5
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Assessment of plasma neuropeptides
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Change from preoperative levels at postoperative day 5
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Changes of syndecan-1
Délai: Change from preoperative levels at postoperative day 5
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Assessment of plasma syndecan-1
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Change from preoperative levels at postoperative day 5
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Changes of thrombomodulin
Délai: Change from preoperative levels at postoperative day 5
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Assessment of plasma thrombomodulin
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Change from preoperative levels at postoperative day 5
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Changes of sVE-cadherin
Délai: Change from preoperative levels at postoperative day 5
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Assessment of plasma sVE-cadherin
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Change from preoperative levels at postoperative day 5
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of patients with major adverse cardiovascular events
Délai: 365 days after surgery
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Defined as:
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365 days after surgery
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Number of patients with postoperative non-cardiovascular complications
Délai: 365 days after surgery
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Defined as:
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365 days after surgery
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Jakob Burcharth, MD, PhD, Zealand University Hospital
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Preiser JC, Ichai C, Orban JC, Groeneveld AB. Metabolic response to the stress of critical illness. Br J Anaesth. 2014 Dec;113(6):945-54. doi: 10.1093/bja/aeu187. Epub 2014 Jun 26.
- Lord JM, Midwinter MJ, Chen YF, Belli A, Brohi K, Kovacs EJ, Koenderman L, Kubes P, Lilford RJ. The systemic immune response to trauma: an overview of pathophysiology and treatment. Lancet. 2014 Oct 18;384(9952):1455-65. doi: 10.1016/S0140-6736(14)60687-5. Epub 2014 Oct 17.
- Munzel T, Sinning C, Post F, Warnholtz A, Schulz E. Pathophysiology, diagnosis and prognostic implications of endothelial dysfunction. Ann Med. 2008;40(3):180-96. doi: 10.1080/07853890701854702.
- McIlroy DR, Chan MT, Wallace SK, Symons JA, Koo EG, Chu LC, Myles PS. Automated preoperative assessment of endothelial dysfunction and risk stratification for perioperative myocardial injury in patients undergoing non-cardiac surgery. Br J Anaesth. 2014 Jan;112(1):47-56. doi: 10.1093/bja/aet354. Epub 2013 Oct 29.
- Huddart S, Peden CJ, Swart M, McCormick B, Dickinson M, Mohammed MA, Quiney N; ELPQuiC Collaborator Group; ELPQuiC Collaborator Group. Use of a pathway quality improvement care bundle to reduce mortality after emergency laparotomy. Br J Surg. 2015 Jan;102(1):57-66. doi: 10.1002/bjs.9658. Epub 2014 Nov 10.
- Marik PE, Bellomo R. Stress hyperglycemia: an essential survival response! Crit Care Med. 2013 Jun;41(6):e93-4. doi: 10.1097/CCM.0b013e318283d124. No abstract available.
- Hassan-Smith Z, Cooper MS. Overview of the endocrine response to critical illness: how to measure it and when to treat. Best Pract Res Clin Endocrinol Metab. 2011 Oct;25(5):705-17. doi: 10.1016/j.beem.2011.04.002.
- Gibbison B, Angelini GD, Lightman SL. Dynamic output and control of the hypothalamic-pituitary-adrenal axis in critical illness and major surgery. Br J Anaesth. 2013 Sep;111(3):347-60. doi: 10.1093/bja/aet077. Epub 2013 May 9.
- Ekeloef S, Larsen MH, Schou-Pedersen AM, Lykkesfeldt J, Rosenberg J, Gogenur I. Endothelial dysfunction in the early postoperative period after major colon cancer surgery. Br J Anaesth. 2017 Feb;118(2):200-206. doi: 10.1093/bja/aew410.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
5 mars 2018
Achèvement primaire (Réel)
1 novembre 2018
Achèvement de l'étude (Réel)
1 novembre 2019
Dates d'inscription aux études
Première soumission
13 février 2018
Première soumission répondant aux critères de contrôle qualité
22 mars 2018
Première publication (Réel)
29 mars 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 janvier 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 janvier 2020
Dernière vérification
1 janvier 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PHASE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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