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

Author

Johannes B Reitsma, Marc J M Bonten, Anne Marie G A de Smet, Remco de Bree, Arjen J C Slooter, Gert-Jan de Borst, Imo E Hoefer, Menno R Vriens, Jelle P Ruurda, Peter Noordzij, Lisette M Vernooij, Ronald P Zweemer, Nikki de Mul, Diede Verlaan, Wilhelmina M U van Grevenstein, Jeroen Hagendoorn, Charles Vogely, Jelle L G Haitsma Mulier, Marcel R de Zoete, Janetta Top, Jan A J Kluijtmans, Thijs Rettig, Marije Marsman, Lennie Derde, Judith van Waes, Mienke Rijsdijk, Willem Jan M Schellekens, and Olaf L Cremer

Subjects
Medicine
Abstract

Purpose 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.Participants 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.Findings to date 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.Future plans 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.Trial registration number NCT05331118.

Published
2023
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2. Cohort profile of PLUTO: a perioperative biobank focusing on prediction and early diagnosis of postoperative complications

Author

Nikki de Mul, Diede Verlaan, Jelle P Ruurda, Wilhelmina M U van Grevenstein, Jeroen Hagendoorn, Gert-Jan de Borst, Menno R Vriens, Remco de Bree, Ronald P Zweemer, Charles Vogely, Jelle L G Haitsma Mulier, Lisette M Vernooij, Johannes B Reitsma, Marcel R de Zoete, Janetta Top, Jan A J Kluijtmans, Imo E Hoefer, Peter Noordzij, Thijs Rettig, Marije Marsman, Anne Marie G A de Smet, Lennie Derde, Judith van Waes, Mienke Rijsdijk, Willem Jan M Schellekens, Marc J M Bonten, Arjen J C Slooter, and Olaf L Cremer

Subjects
General Medicine
Abstract

PurposeAlthough 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.ParticipantsPatients 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.Findings to dateEnrolment 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.Future plansThe 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.Trial registration numberNCT05331118.

Published
2023

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