Surgery-ComplicationsAI_PLUSNCT06166719
Prediction of Complications After Major Gastrointestinal Surgery With Machine Learning and Point of Care Ultrasound
An observational study of Surgery-Complications and Overload Fluid, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
This is an observational study in patients undergoing major surgery. In which we attempt to predict complications (e.g. low blood pressure, ICU-admittance after major surgery using continuous blood pressure measurements. We will also attempt to predict their response to fluid therapy using point of care ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery-Complications, Overload Fluid
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Nov 2023to 20 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Adult patients who will undergo elective, major gastrointestinal surgery.
Who may be able to join
- ≥18 years of age.
- elective major gastrointestinal surgery: esophagectomy, gastrectomy, pancreatomy or major liver resection (3 segments or more).
Who cannot join
- no informed consent
- Patients with major cardiac shunts
- Patients with dialysis shunts or peritoneal dialysis
- Patients in whom POCUS is not possible or assessment of fluid status is unreliable e.g. BMI> 40, pulmonary fibrosis.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1081HV
A.P. J. Vlaar, PhD, 020 444 4444, a.p.vlaar@amsterdamumc.nl
About this study
Official title: Prediction of Complications After Major Gastrointestinal Surgery With Machine Learning and Point of Care Ultrasound: an Observational Cohort Study.
This is an observational study in patients undergoing major surgery. In which we attempt to predict complications (e.g. low blood pressure, ICU-admittance after major surgery using continuous blood pressure measurements. We will also attempt to predict their response to fluid therapy using point of care ultrasound. Eventually we aim to combine these methods to detect complications earlier and to give advice about whether or not administration of fluid is appropriate
Read the detailed description
The primary aim of this study is to develop a machine learning framework to predict major complications after major gastro-intestinal surgery. Secondary aims include combining this framework with point of care ultrasound to determine the best initial resuscitative strategy; and to determine which ultrasound parameters are best predictive of fluid intolerance. Furthermore if the renin angiotensin aldosterone system is more active after liver resection.
Study design:
Single centre observational cohort study
Study population:
Adult patients undergoing elective major gastrointestinal surgery
Primary study parameters/outcome of the study:
The main study endpoint is a machine learning framework based on the hemodynamic profile to predict major complications,especially cardiovascular/pulmonary instability, including, sepsis and septic shock. Data from the ClearSight will be used to collect non-invasive arterial pressure waveforms. point of care ultrasound of heart, lungs and abdominal veins, and clinical data from the electronic medical record will be collected
Secondary study parameters/outcome of the study (if applicable):
point of care ultrasound of heart, lungs and abdominal veins, and clinical data from the electronic medical record will be collected. Ina subgroup of 40 patients RAAS levels and portal blood samples will be analysed.
- Conditions
- Surgery-Complications, Overload Fluid
- Being tested
- No intervention
- Keywords
- Intensive care unit, Gastro-intestinal surgery, Prediction
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complications
mainly complications such as ICU admission, re-OR, hemodynamic or respiratory instability, death, organ failure
Measured: 28 days
Secondary outcomes (1)
fluid overload or fluid intolerance
ultrasound measurements such as lung ultrasound and VExUS
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start20 Nov 2023
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Jan 2026 (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 Surgery-ComplicationsStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, A.P.J. Vlaar, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- A.P. J. Vlaar, PhD, Principal investigator, Department of Intensive Care, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166719
- Sponsor's protocol ID
- NL84107.018.23
- Acronym
- AI_PLUS
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: As of this moment it is undecided whether or not the individual patient data will be made available
Publications
Klompmaker P, Plantinga C, den Otter CA, van Zwol J, Oomes PPCH, Kho E, Schenk J, Berge-Henegouwen MI, Erdmann JI, Vlaar APJ, Veelo DP, Tuinman PR. Ultrasound assessment of fluid tolerance in patients undergoing major gastrointestinal surgery: epidemiology of pulmonary and systemic congestion. Br J Anaesth. 2026 Oct 29:S0007-0912(26)00743-9. doi: 10.1016/j.bja.2026.09.022. Online ahead of print.
PubMed 42957498
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Complications After Major Gastrointestinal Surgery With Machine Learning and Point of Care Ultrasound: an Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT06166719
- Acronym / sponsor ID
- AI_PLUS / NL84107.018.23
- Conditions
- Surgery-Complications, Overload Fluid
- Keywords
- Intensive care unit, Gastro-intestinal surgery, Prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Jan 2026 (estimated)
- First posted
- 12 Dec 2023 (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.
This is an observational study in patients undergoing major surgery. In which we attempt to predict complications (e.g. low blood pressure, ICU-admittance after major surgery using continuous blood pressure measurements. We will also attempt to predict their response to fluid therapy using point of care ultrasound. Eventually we aim to combine these methods to detect complications earlier and to give advice about whether or not administration of fluid is appropriate
Detailed description
The primary aim of this study is to develop a machine learning framework to predict major complications after major gastro-intestinal surgery. Secondary aims include combining this framework with point of care ultrasound to determine the best initial resuscitative strategy; and to determine which ultrasound parameters are best predictive of fluid intolerance. Furthermore if the renin angiotensin aldosterone system is more active after liver resection.
Study design:
Single centre observational cohort study
Study population:
Adult patients undergoing elective major gastrointestinal surgery
Primary study parameters/outcome of the study:
The main study endpoint is a machine learning framework based on the hemodynamic profile to predict major complications,especially cardiovascular/pulmonary instability, including, sepsis and septic shock. Data from the ClearSight will be used to collect non-invasive arterial pressure waveforms. point of care ultrasound of heart, lungs and abdominal veins, and clinical data from the electronic medical record will be collected
Secondary study parameters/outcome of the study (if applicable):
point of care ultrasound of heart, lungs and abdominal veins, and clinical data from the electronic medical record will be collected. Ina subgroup of 40 patients RAAS levels and portal blood samples will be analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients who will undergo elective, major gastrointestinal surgery.
Key inclusion criteria (2 listed)
- ≥18 years of age.
- elective major gastrointestinal surgery: esophagectomy, gastrectomy, pancreatomy or major liver resection (3 segments or more).
Key exclusion criteria (4 listed)
- no informed consent
- Patients with major cardiac shunts
- Patients with dialysis shunts or peritoneal dialysis
- Patients in whom POCUS is not possible or assessment of fluid status is unreliable e.g. BMI> 40, pulmonary fibrosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Post-operative complications
Time frame: 28 days
mainly complications such as ICU admission, re-OR, hemodynamic or respiratory instability, death, organ failure
1 secondary outcome
fluid overload or fluid intolerance
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Derived from this study: PubMed 42957498Klompmaker P, Plantinga C, den Otter CA, van Zwol J, Oomes PPCH, Kho E, Schenk J, Berge-Henegouwen MI, Erdmann JI, Vlaar APJ, Veelo DP, Tuinman PR. Ultrasound assessment of fluid tolerance in patients undergoing major gastrointestinal surgery: epidemiology of pulmonary and systemic congestion. Br J Anaesth. 2026 Oct 29:S0007-0912(26)00743-9. doi: 10.1016/j.bja.2026.09.022. Online ahead of print.
- Individual participant dataSharing planned: Undecided. As of this moment it is undecided whether or not the individual patient data will be made available
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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. This study is not recruiting at the moment.
A.P. J. Vlaar, PhD principal investigator
Department of Intensive Care, Amsterdam UMC
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 Surgery-Complications and Overload Fluid, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 2 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: status not confirmed, as of the sponsor's last update on 22 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact P. Klompmaker, PhD (020 444 4444, p.klompmaker@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative complications (time frame: 28 days). 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 NCT06166719, 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 22 Dec 2023.