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

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.

Cohort profile of BIGPROMISE: a perioperative biobank of a high-risk surgical population

“…To enable research collaborations in the field of perioperative medicine, the outcome parameters of BIGPROMISE are defined according to international standards as described in PLUTO (perioperative longitudinal study of complications and long-term outcomes). 42 The design of the BIGPROMISE biobank is based on the results of scientific research and the social interest in reducing the harmful consequences of postoperative complications. Data and biomaterials from BIGPROMISE can be used for future research within the scope of the scientific aim of the study and the informed consent provided by participants: to facilitate biomarker research on risk factors, pathophysiology and outcomes related to postoperative complications.…”