NCT05331118 Perioperative Longitudinal Study of Complications and Long-term Outcomes
| NCT ID | NCT05331118 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UMC Utrecht |
| Condition | Perioperative Complication |
| Study Type | OBSERVATIONAL |
| Enrollment | 9,000 participants |
| Start Date | 2020-02-21 |
| Primary Completion | 2040-02-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 9,000 participants in total. It began in 2020-02-21 with a primary completion date of 2040-02-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Purpose: with an increased risk of complications. Improved preoperative risk stratification and earlier diagnosis of these complications may ameliorate postoperative recovery and improve long-term outcomes. The perioperative longitudinal study of complications and long-term outcomes (PLUTO) aims to establish a comprehensive biorepository that will facilitate research in this field. Patients undergoing elective intermediate to high-risk non-cardiac surgery are eligible for enrolment. For the first 7 postoperative days (or longer as indicated), participants will be subjected to daily bedside visits by dedicated observers, who adjudicate clinical events and perform non-invasive physiological measurements (including handheld spirometry and single-channel EEG). In addition, we will collect blood samples as well as microbiome specimens at selected time points. Primary study outcomes are the postoperative occurrence of nosocomial infections, major adverse cardiac events, pulmonary complications, acute kidney injury and delirium. Secondary outcomes include mortality as well as long-term psychopathology, cognitive dysfunction, and quality of life. PLUTO is the first perioperative biobank worldwide that includes a broad range of high-risk surgical patients, collecting prospective bedside data as well as both blood and microbiome specimens during the entire perioperative period. The data and materials collected in PLUTO will be used to develop, externally validate, and update prognostic prediction models for improved risk assessment, to test novel biomarkers for early detection of postoperative complications and to study the aetiology, attributable morbidity and mortality related to these events.
Eligibility Criteria
Inclusion Criteria: \- Undergoing an elective, high-risk gastro-intestinal or vascular procedure, or intermediate risk procedure (including gynaecological, orthopaedic and head and neck surgery) if the procedure includes a laparotomy and/or is associated with a scheduled hospital length of stay ≥ 5 days. Exclusion Criteria: * \< 18 years of age * Emergency surgery * Severe anaemia (Hb \< 4.5 mmol/L) * Unable to provide informed consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05331118 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Perioperative Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05331118 currently recruiting?
Yes, NCT05331118 is actively recruiting participants. Contact the research team at PLUTO@umcutrecht.nl for enrollment information.
Where is the NCT05331118 trial being conducted?
This trial is being conducted at Utrecht, Netherlands.
Who is sponsoring the NCT05331118 clinical trial?
NCT05331118 is sponsored by UMC Utrecht. The trial plans to enroll 9,000 participants.