Cohort profile of PLUTO: a perioperative biobank focusing on prediction and early diagnosis of postoperative complications.
Nikki de Mul, Diede Verlaan, Jelle P Ruurda...
https://pubmed.ncbi.nlm.nih.gov/37076142Actively Recruiting
Led by UMC Utrecht · Updated on 2023-11-29
9000
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying patients undergoing elective intermediate to high-risk non-cardiac surgery to better understand and predict complications that can affect recovery and long-term health. This observational study aims to create a large biorepository by collecting detailed clinical data, blood samples, and microbiome specimens throughout the perioperative period. The goal is to improve risk assessment, detect complications early, and explore the causes and effects of these events on patient outcomes. Participants include adults having elective high-risk gastrointestinal or vascular surgery, or intermediate risk surgeries such as gynecological, orthopedic, or head and neck procedures that involve laparotomy or a hospital stay of five days or more. During the first seven days after surgery, or longer if needed, trained observers visit patients daily at their bedside to record clinical events and perform non-invasive tests like handheld spirometry and single-channel EEG. Blood and microbiome samples are collected at specific times to support biomarker research. Throughout the study, participants will undergo continuous monitoring for infections, heart events, lung complications, kidney injury, and delirium during their hospital stay. Additional evaluations include pain tracking, complication severity, and assessments of mental health, cognitive function, and survival up to one year after surgery. The data gathered will help develop prediction models and improve understanding of postoperative risks and recovery. The overall participation duration varies depending on individual recovery and follow-up assessments.
CONDITIONS
Perioperative Longitudinal Study of Complications and Long-term Outcomes
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of hospital admission
Participants are observed for complications and outcomes during their hospital admission.
Visits during hospital stay as per routine care
Duration - Up to 1 year after surgery
Participants are followed up for long-term outcomes including psychopathology, cognitive dysfunction, and mortality.
1 visit at 1-year follow-up
Total: 1 location
1
University Medical Center Utrecht
Utrecht, Netherlands, 3584CX
Actively Recruiting
N
Nikki de Mul, MSc
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Nikki de Mul, Diede Verlaan, Jelle P Ruurda...
https://pubmed.ncbi.nlm.nih.gov/37076142