Perioperative ComplicationPLUTONCT05331118
Perioperative Longitudinal Study of Complications and Long-term Outcomes
An observational study of Perioperative Complication and Infections, run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Complication, Infections, Myocardium; Injury
- How many people
- 9,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Feb 2020to 21 Feb 2040
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- < 18 years of age
- Emergency surgery
- Severe anaemia (Hb < 4.5 mmol/L)
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, 3584CX
Nikki de Mul, +31887561124, PLUTO@umcutrecht.nl
About this study
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.
- Medical subject headings
- Infections, Wounds and Injuries, Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative infectious complications
Infectious complications are defined according to Centers for Disease Control and prevention (CDC) criteria and International Sepsis Forum consensus definitions. A comprehensive list of diagnostic criteria, as well as an assessment of the interobserver agreement associated with these, has previously been published in Klein Klouwenberg, Crit Care Med 2013; 41:2373-8. Since these definitions are in agreement with the CDC criteria used in the EPCO definitions, they did not have to be modified for the PLUTO project. For all events, the post hoc probability of true infection will be categorized using a four-point scale (none, possible, probable, and definite infection). This enables us to distinguish cases with true infection from cases with, for example, postoperative systemic inflammation.
Measured: During hospital admission
Postoperative Pulmonary Complications (PPC)
Postoperative pulmonary complications are registered according to the European Perioperative Clinical Outcome (EPCO) definitions. A postoperative pulmonary complication is registered if (1) the patient has a saturation below 90%, (2) the patients oxygen consumption is exceeding 5L/min or (3) the patient's saturation is below 94% while on oxygen therapy. In addition to clinical signs and symptoms, radiology findings, diagnoses and instituted therapies part of the EPCO definitions, duration of the episode and diagnostic modalities used to obtain the diagnosis (e.g. chest x-ray, CT, arterial blood gas, etc.) are registered.
Measured: During hospital admission
Major Adverse Cardiac Events (MACE)
Major Adverse Cardiac Events (MACE) are registered according to the StEP definitions. In addition, the items of the EPCO definition for MACE are included in the registration and all cardiovascular complications included in both these consensus definitions can therefore be reconstructed from the PLUTO database and easily be compared to other perioperative outcome studies. For every patient of 60 years and older, daily troponins are obtained every morning on the first three postoperative days. Daily, an anaesthesiologists assess the troponin values and institutes further diagnostic testing as indicated. For the remaining postoperative days and for patients younger than 60 years of age, troponin is measured on clinical indication.
Measured: During hospital admission
Acute Kidney Injury (AKI)
Acute Kidney Injury (AKI) is defined according to the Risk, Injury, Failure, Loss of kidney function and End-stage kidney disease (RIFLE) criteria. The chart of the patients is assessed on a daily basis for information on urine production and creatinine / kidney function.
Measured: During hospital admission
Delirium
Delirium, defined as either a positive CAM(-ICU) or ≥ 4 points on the AT4.
Measured: During hospital admission
Secondary outcomes (5)
Complication severity grade
Severity of all surgical complications is assessed according to the Clavien-Dindo classification.
Measured: During hosptial admission
Acute pain
Daily pain scores, both in rest and during activity, are measured via the Numeric Rating Scale (NRS). This score ranges from 0 to 10, with 0 being absolutely no pain at all and 10 being the worst imaginable pain.
Measured: During first 7 days
Long-term psychopathology
Long-term psychopathology, defined as symptoms for depression, anxiety and/or post-traumatic stress syndrome (PTSS). Depression is defined as a score ≥ 8 on the HADS-D and anxiety as a score ≥ 8 on the HADS-A. For the IES-R, an item mean score threshold of 1.6 will be used.
Measured: At 1 year follow-up
Cognitive dysfunction
Cognitive dysfunction, as measured by the Cognitive Failure Questionnaire.
Measured: At 1-year follow-up
Mortality
In-hospital mortality, 30-day mortality, one-year mortality and days alive outside of the hospital in the first 30 days following surgery.
Measured: During first year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start21 Feb 2020
- Primary completion21 Feb 2040 (estimated)
- Study completion21 Feb 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, O.L. (Olaf) Cremer, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331118
- Sponsor's protocol ID
- TCBio_19-514
- Acronym
- PLUTO
- Status last verified
- Nov 2023
- First submitted
- 8 Apr 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
de Mul N, Verlaan D, Ruurda JP, van Grevenstein WMU, Hagendoorn J, de Borst GJ, Vriens MR, de Bree R, Zweemer RP, Vogely C, Haitsma Mulier JLG, Vernooij LM, Reitsma JB, de Zoete MR, Top J, Kluijtmans JAJ, Hoefer IE, Noordzij P, Rettig T, Marsman M, de Smet AMGA, Derde L, van Waes J, Rijsdijk M, Schellekens WJM, Bonten MJM, Slooter AJC, Cremer OL. Cohort profile of PLUTO: a perioperative biobank focusing on prediction and early diagnosis of postoperative complications. BMJ Open. 2023 Apr 19;13(4):e068970. doi: 10.1136/bmjopen-2022-068970.
PubMed 37076142
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Longitudinal Study of Complications and Long-term Outcomes
- ClinicalTrials.gov ID
- NCT05331118
- Acronym / sponsor ID
- PLUTO / TCBio_19-514
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 21 Feb 2040 (estimated)
- Study completion
- 21 Feb 2040 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- < 18 years of age
- Emergency surgery
- Severe anaemia (Hb < 4.5 mmol/L)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perioperative infectious complications
Time frame: During hospital admission
Infectious complications are defined according to Centers for Disease Control and prevention (CDC) criteria and International Sepsis Forum consensus definitions. A comprehensive list of diagnostic criteria, as well as an assessment of the interobserver agreement associated with these, has previously been published in Klein Klouwenberg, Crit Care Med 2013; 41:2373-8. Since these definitions are in agreement with the CDC criteria used in the EPCO definitions, they did not have to be modified for the PLUTO project. For all events, the post hoc probability of true infection will be categorized using a four-point scale (none, possible, probable, and definite infection). This enables us to distinguish cases with true infection from cases with, for example, postoperative systemic inflammation.
Postoperative Pulmonary Complications (PPC)
Time frame: During hospital admission
Postoperative pulmonary complications are registered according to the European Perioperative Clinical Outcome (EPCO) definitions. A postoperative pulmonary complication is registered if (1) the patient has a saturation below 90%, (2) the patients oxygen consumption is exceeding 5L/min or (3) the patient's saturation is below 94% while on oxygen therapy. In addition to clinical signs and symptoms, radiology findings, diagnoses and instituted therapies part of the EPCO definitions, duration of the episode and diagnostic modalities used to obtain the diagnosis (e.g. chest x-ray, CT, arterial blood gas, etc.) are registered.
Major Adverse Cardiac Events (MACE)
Time frame: During hospital admission
Major Adverse Cardiac Events (MACE) are registered according to the StEP definitions. In addition, the items of the EPCO definition for MACE are included in the registration and all cardiovascular complications included in both these consensus definitions can therefore be reconstructed from the PLUTO database and easily be compared to other perioperative outcome studies. For every patient of 60 years and older, daily troponins are obtained every morning on the first three postoperative days. Daily, an anaesthesiologists assess the troponin values and institutes further diagnostic testing as indicated. For the remaining postoperative days and for patients younger than 60 years of age, troponin is measured on clinical indication.
Acute Kidney Injury (AKI)
Time frame: During hospital admission
Acute Kidney Injury (AKI) is defined according to the Risk, Injury, Failure, Loss of kidney function and End-stage kidney disease (RIFLE) criteria. The chart of the patients is assessed on a daily basis for information on urine production and creatinine / kidney function.
Delirium
Time frame: During hospital admission
Delirium, defined as either a positive CAM(-ICU) or ≥ 4 points on the AT4.
5 secondary outcomes
Complication severity grade
Time frame: During hosptial admission
Acute pain
Time frame: During first 7 days
Long-term psychopathology
Time frame: At 1 year follow-up
Cognitive dysfunction
Time frame: At 1-year follow-up
Mortality
Time frame: During first year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 37076142de Mul N, Verlaan D, Ruurda JP, van Grevenstein WMU, Hagendoorn J, de Borst GJ, Vriens MR, de Bree R, Zweemer RP, Vogely C, Haitsma Mulier JLG, Vernooij LM, Reitsma JB, de Zoete MR, Top J, Kluijtmans JAJ, Hoefer IE, Noordzij P, Rettig T, Marsman M, de Smet AMGA, Derde L, van Waes J, Rijsdijk M, Schellekens WJM, Bonten MJM, Slooter AJC, Cremer OL. Cohort profile of PLUTO: a perioperative biobank focusing on prediction and early diagnosis of postoperative complications. BMJ Open. 2023 Apr 19;13(4):e068970. doi: 10.1136/bmjopen-2022-068970.
- Individual participant dataSharing planned: Yes
Related trials for Perioperative Complication
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Active, not recruiting
Prehabilitation in Pancreatic Surgery
Pancreatic Cancer, Periampullary Cancer
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Complication and Infections, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikki de Mul, MSc (+31887561124, PLUTO@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative infectious complications (time frame: During hospital admission). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05331118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.