Clinical trial NCT05331118: Perioperative Longitudinal Study of Complications and Long-term Outcomes
Official title: Perioperative Longitudinal Study of Complications and Long-term Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perioperative Complication
Infections
Myocardium; Injury
Kidney Injury
Delirium
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 9000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing high risk surgery and a selection of intermediate risk procedure as defined by the Surgical Mortality Probability Model. Patients are selected based on procedural risk alone, as we explicitly aim to enrol subjects across a wide range of patient-specific risk factors.

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

Primary outcomes:
measure: Perioperative infectious complications
timeFrame: During hospital admission
measure: Postoperative Pulmonary Complications (PPC)
timeFrame: During hospital admission
measure: Major Adverse Cardiac Events (MACE)
timeFrame: During hospital admission
measure: Acute Kidney Injury (AKI)
timeFrame: During hospital admission
measure: Delirium
timeFrame: During hospital admission
Secondary outcomes:
measure: Complication severity grade
timeFrame: During hosptial admission
measure: Acute pain
timeFrame: During first 7 days
measure: Long-term psychopathology
timeFrame: At 1 year follow-up
measure: Cognitive dysfunction
timeFrame: At 1-year follow-up
measure: Mortality
timeFrame: During first year
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References: