Cohort profile of PLUTO: a perioperative biobank focusing on prediction and early diagnosis of postoperative complications.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
19 04 2023
Historique:
medline: 21 4 2023
pubmed: 20 4 2023
entrez: 19 04 2023
Statut: epublish

Résumé

Although elective surgery is generally safe, some procedures remain associated with an increased risk of complications. Improved preoperative risk stratification and earlier recognition of these complications may ameliorate postoperative recovery and improve long-term outcomes. The perioperative longitudinal study of complications and long-term outcomes (PLUTO) cohort aims to establish a comprehensive biorepository that will facilitate research in this field. In this profile paper, we will discuss its design rationale and opportunities for future studies. Patients undergoing elective intermediate to high-risk non-cardiac surgery are eligible for enrolment. For the first seven postoperative days, participants are subjected to daily bedside visits by dedicated observers, who adjudicate clinical events and perform non-invasive physiological measurements (including handheld spirometry and single-channel electroencephalography). Blood samples and microbiome specimens are collected at preselected time points. Primary study outcomes are the postoperative occurrence of nosocomial infections, major adverse cardiac events, pulmonary complications, acute kidney injury and delirium/acute encephalopathy. Secondary outcomes include mortality and quality of life, as well as the long-term occurrence of psychopathology, cognitive dysfunction and chronic pain. Enrolment of the first participant occurred early 2020. During the inception phase of the project (first 2 years), 431 patients were eligible of whom 297 patients consented to participate (69%). Observed event rate was 42% overall, with the most frequent complication being infection. The main purpose of the PLUTO biorepository is to provide a framework for research in the field of perioperative medicine and anaesthesiology, by storing high-quality clinical data and biomaterials for future studies. In addition, PLUTO aims to establish a logistical platform for conducting embedded clinical trials. NCT05331118.

Identifiants

pubmed: 37076142
pii: bmjopen-2022-068970
doi: 10.1136/bmjopen-2022-068970
pmc: PMC10124280
doi:

Banques de données

ClinicalTrials.gov
['NCT05331118']

Types de publication

Clinical Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e068970

Informations de copyright

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Nikki de Mul (N)

Department of Anaesthesiology, UMC Utrecht, Utrecht, The Netherlands n.demul-3@umcutrecht.nl.
Department of Intensive Care Medicine, UMC Utrecht, Utrecht, The Netherlands.
Julius Center, Department of Epidemiology, Program of Infectious Diseases, UMC Utrecht, Utrecht, The Netherlands.

Diede Verlaan (D)

Department of Intensive Care Medicine, UMC Utrecht, Utrecht, The Netherlands.
Julius Center, Department of Epidemiology, Program of Infectious Diseases, UMC Utrecht, Utrecht, The Netherlands.

Jelle P Ruurda (JP)

Department of Surgical Oncology, Upper Gastro-Intestinal Surgery, UMC Utrecht, Utrecht, The Netherlands.

Wilhelmina M U van Grevenstein (WMU)

Department of Surgical Oncology, General Surgery, UMC Utrecht, Utrecht, The Netherlands.

Jeroen Hagendoorn (J)

Department of Surgical Oncology, Hepatobilliary and Pancreatic Surgery, UMC Utrecht, Utrecht, The Netherlands.

Gert-Jan de Borst (GJ)

Department of Vascular Surgery, UMC Utrecht, Utrecht, The Netherlands.

Menno R Vriens (MR)

Department of Endocrine and Surgical Oncology, Cancer Center, UMC Utrecht, Utrecht, The Netherlands.

Remco de Bree (R)

Department of Head and Neck Surgical Oncology, UMC Utrecht, Utrecht, The Netherlands.

Ronald P Zweemer (RP)

Department of Gynaecological Oncology, UMC Utrecht, Utrecht, The Netherlands.

Charles Vogely (C)

Department of Orthopaedic Surgery, UMC Utrecht, Utrecht, The Netherlands.

Jelle L G Haitsma Mulier (JLG)

Department of Intensive Care Medicine, UMC Utrecht, Utrecht, The Netherlands.
Julius Center, Department of Epidemiology, Program of Infectious Diseases, UMC Utrecht, Utrecht, The Netherlands.

Lisette M Vernooij (LM)

Department of Anaesthesiology, UMC Utrecht, Utrecht, The Netherlands.
Department of Intensive Care Medicine, UMC Utrecht, Utrecht, The Netherlands.
Department of Anaesthesiology and Intensive Care, Antonius Ziekenhuis Nieuwegein, Nieuwegein, The Netherlands.

Johannes B Reitsma (JB)

Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht, The Netherlands.

Marcel R de Zoete (MR)

Department of Medical Microbiology, UMC Utrecht, Utrecht, The Netherlands.

Janetta Top (J)

Department of Medical Microbiology, UMC Utrecht, Utrecht, The Netherlands.

Jan A J Kluijtmans (JAJ)

Department of Medical Microbiology, UMC Utrecht, Utrecht, The Netherlands.

Imo E Hoefer (IE)

Central Diagnostic Laboratory, Universitair Medisch Centrum, Utrecht, The Netherlands.

Peter Noordzij (P)

Department of Anaesthesiology and Intensive Care, Antonius Ziekenhuis Nieuwegein, Nieuwegein, The Netherlands.

Thijs Rettig (T)

Department of Anesthesiology, Intensive Care and Pain Medicine, Amphia Hospital site Molengracht, Breda, The Netherlands.

Marije Marsman (M)

Department of Anaesthesiology, UMC Utrecht, Utrecht, The Netherlands.

Anne Marie G A de Smet (AMGA)

Department of Intensive Care Medicine, UMC Utrecht, Utrecht, The Netherlands.

Lennie Derde (L)

Department of Intensive Care Medicine, UMC Utrecht, Utrecht, The Netherlands.

Judith van Waes (J)

Department of Anaesthesiology, UMC Utrecht, Utrecht, The Netherlands.

Mienke Rijsdijk (M)

Department of Anaesthesiology, UMC Utrecht, Utrecht, The Netherlands.

Willem Jan M Schellekens (WJM)

Department of Anaesthesiology, UMC Utrecht, Utrecht, The Netherlands.
Department of Anaesthesiology, Cantonal Hospital Aarau, Aarau, Switzerland.

Marc J M Bonten (MJM)

Julius Center, Department of Epidemiology, Program of Infectious Diseases, UMC Utrecht, Utrecht, The Netherlands.

Arjen J C Slooter (AJC)

Department of Intensive Care Medicine, UMC Utrecht, Utrecht, The Netherlands.

Olaf L Cremer (OL)

Department of Intensive Care Medicine, UMC Utrecht, Utrecht, The Netherlands.

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