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Individualised perioperative blood pressure and fluid therapy in oesophagectomy ­ study protocol for a randomised clinical trial
Hovgaard, Henrik Lynge; Vistisen, Simon; Enevoldsen, Johannes; de Paoli, Frank; Scheeren, Thomas Wl; Katballe, Niels; Kjaer, Daniel W; Linnemann, Gerhard; Jørgensen, Martin Rs; Karaliunaite, Zidryne; Jeppesen, Anni Nørgaard; Juhl-Olsen, Peter.
Afiliação
  • Hovgaard HL; Anaesthesia Section, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital.
  • Vistisen S; Department of Clinical Medicine, Aarhus University Hospital.
  • Enevoldsen J; Department of Anaesthesia and Intensive Care, Aarhus University Hospital.
  • de Paoli F; Anaesthesia Section, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital.
  • Scheeren TW; Department of Biomedicine, Aarhus University Hospital, Denmark.
  • Katballe N; Department fo Anaesthesiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
  • Kjaer DW; Edwards Lifesciences, Unterschleissheim, Germany.
  • Linnemann G; Anaesthesia Section, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital.
  • Jørgensen MR; Department of Surgery, Aarhus University Hospital, Denmark.
  • Karaliunaite Z; Anaesthesia Section, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital.
  • Jeppesen AN; Anaesthesia Section, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital.
  • Juhl-Olsen P; Anaesthesia Section, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital.
Dan Med J ; 70(5)2023 04 24.
Article em En | MEDLINE | ID: mdl-37125828
INTRODUCTION: Oesophagectomy is the mainstay of curative treatment for oesophageal cancer, but it is associated with a high risk of major complications. Goal-directed fluid therapy and individualised blood pressure management may prevent complications after surgery. Extending goal-directed fluid therapy after surgery and applying an individual blood pressure target may have substantial benefit in oesophagectomy. This is a protocol for a clinical trial implementing a novel haemodynamic protocol from the start of anaesthesia to the next day with the patient's own night-time blood pressure as the lower threshold. METHODS: This is a single-centre, single-blind, randomised, clinical trial. Oesophagectomy patients are randomised 1:1 for either perioperative haemodynamic management according to a goal-directed fluid therapy protocol with an individual target blood pressure or for standard care. The primary endpoint is the total burden of morbidity and mortality assessed by the Comprehensive Complication Index 30 days after surgery. Secondary endpoints are complications, reoperations, fluid and vasopressor dosage and quality of life at 90 days after surgery. CONCLUSIONS: The results from this trial provide an objective and easy-to-follow algorithm for fluid administration, which may improve patient-centred outcomes in oesophagectomy patients. FUNDING: The trial is supported by Aarhus University (1,293,400 DKK) and the Novo Nordisk Foundation (625,200 DKK). TRIAL REGISTRATION: EudraCT number: 2021-002816-30.
Assuntos
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Coleções: 01-internacional Contexto em Saúde: 6_ODS3_enfermedades_notrasmisibles Base de dados: MEDLINE Assunto principal: Qualidade de Vida / Doenças Cardiovasculares Tipo de estudo: Clinical_trials / Guideline Aspecto: Patient_preference Limite: Humans Idioma: En Revista: Dan Med J Ano de publicação: 2023 Tipo de documento: Article
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Coleções: 01-internacional Contexto em Saúde: 6_ODS3_enfermedades_notrasmisibles Base de dados: MEDLINE Assunto principal: Qualidade de Vida / Doenças Cardiovasculares Tipo de estudo: Clinical_trials / Guideline Aspecto: Patient_preference Limite: Humans Idioma: En Revista: Dan Med J Ano de publicação: 2023 Tipo de documento: Article