Surgery--ComplicationsODIN-ReportNCT03974828
Telemedicine Notifications With Machine Learning for Postoperative Care
A study of Surgery--Complications and Perioperative/Postoperative Complications, run by Washington University School of Medicine.
Trial summary
The ODIN-Report study will be a randomized controlled trial of the effect of providing machine learning risk forecasts to providers caring for patients immediately after surgery on serious complications. The complications studied will be ICU admission or death on wards, acute kidney injury, and hospital length of stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications, Perioperative/Postoperative Complications, Acute Kidney Injury
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2025to 6 Oct 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in TECTONICS Study (ID 201903026, NCT03923699), in OR randomized to contact
- workweek hours
- preoperative assessment completed
- estimated risk of mortality in top 15% of historical PACU patients
Who cannot join
- Not enrolled in TECTONICS Study
- Operating room randomized to non-contact in TECTONICS
- Planned ICU admission
About this study
The ODIN-Report study will be a randomized controlled trial of the effect of providing machine learning risk forecasts to providers caring for patients immediately after surgery on serious complications. The complications studied will be ICU admission or death on wards, acute kidney injury, and hospital length of stay.
Read the detailed description
This will be a single center, randomized, controlled, pragmatic clinical trial. The investigators will screen surgical patients enrolled in TECTONICS (NCT03923699) and randomized to intraoperative contact. Near the end of the operation, the investigators will calculate the same machine learning risk forecasts of major complications as TECTONICS, and enroll patients if all of the following are true: (1) No ICU admission is intended (2) ML mortality risk forecast is in top 15% of historical PACU patients.
Patients will be randomized 1:1:1 to no contact, brief contact, and full contact. The postoperative provider (PACU physician, anesthesiologist, ward clinician) will be notified before arrival of the risk forecast in the contact groups, and in the full contact group an additional set of explanatory ML outputs will be provided. The intention-to-treat principle will be followed for all analyses.
- Conditions
- Surgery--Complications, Perioperative/Postoperative Complications, Acute Kidney Injury, Hospital Mortality
- Being tested
- Anesthesia Control Tower Notification
- Keywords
- Telemedicine, Anesthesia Control Tower, Machine Learning, Forecasting Algorithms, Randomized Controlled Trial, PACU
- Medical subject headings
- Postoperative Complications, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia Control Tower NotificationDevice
Real-time data will be monitored through the AlertWatch system as well as the electronic health record. Risk forecasts of adverse events (30 day mortality, acute kidney injury, postoperative delirium, respiratory failure), PACU length of stay, and hospital length of stay will be generated by a machine learning algorithm. Additional outputs identifying the most important predictors and their effects will be combined with risk forecasts to form a report card.
| Study group | Role | What they receive |
|---|---|---|
| Non-Contact | No intervention | Participants in the non-contact group will be monitored by anesthesia control tower clinicians who will utilize AlertWatch and integrating machine-learning forecasting algorithms for adverse outcomes predictions, but who will not contact the postoperative provider unless it is clinically necessary for patient safety purposes. |
| Brief contact | Experimental | PACU and ward providers caring for participants in the brief contact group will be notified by Anesthesia Control Tower clinicians before arrival if the patient's forecast for mortality is in the top 15% of historical PACU patients. The notification will contain a brief summary of the patient's forecast risk of major adverse events. Receives: Device: Anesthesia Control Tower Notification |
| Full contact | Experimental | PACU and ward providers caring for participants in the full contact group will be notified by Anesthesia Control Tower clinicians before arrival if the patient's forecast for mortality is in the top 15% of historical PACU patients. The notification will contain a report card of the patient's forecast risk of major adverse events, explanatory machine-learning outputs, most influential pre- and intraoperative data, and predicted treatments. Receives: Device: Anesthesia Control Tower Notification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned ICU admission
Admission to a "critical care" bed regardless of rationale or duration at any point in the follow up time frame. Patients who expire without transfer to ICU will be marked as positive.
Measured: 7 days post-op
Secondary outcomes (2)
Acute Kidney Injury
Postoperative laboratory values and urine output will be used to calculate Kidney Disease Improving Global Outcomes grades of acute kidney injury. Where unavailable, baseline Glomerular filtration rate will be assumed to be age, sex, and body size normal.
Measured: 7 days post-op
Hospital length of stay
The duration in days between end of anesthesia care and discharge from the performing hospital.
Measured: 30 days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start6 Oct 2025
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1:1 randomization between standard of care (no contact), postoperative contact (brief), postoperative contact (long).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher R King, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974828
- Sponsor's protocol ID
- 201905127
- Acronym
- ODIN-Report
- Status last verified
- May 2026
- First submitted
- 2 Jun 2019
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data are a subset of TECTONICS and will be have the same sharing plan / restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Notifications With Machine Learning for Postoperative Care
- ClinicalTrials.gov ID
- NCT03974828
- Acronym / sponsor ID
- ODIN-Report / 201905127
- Conditions
- Surgery--Complications, Perioperative/Postoperative Complications, Acute Kidney Injury, Hospital Mortality
- Keywords
- Telemedicine, Anesthesia Control Tower, Machine Learning, Forecasting Algorithms, Randomized Controlled Trial, PACU
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 5 Jun 2019 (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.
The ODIN-Report study will be a randomized controlled trial of the effect of providing machine learning risk forecasts to providers caring for patients immediately after surgery on serious complications. The complications studied will be ICU admission or death on wards, acute kidney injury, and hospital length of stay.
Detailed description
This will be a single center, randomized, controlled, pragmatic clinical trial. The investigators will screen surgical patients enrolled in TECTONICS (NCT03923699) and randomized to intraoperative contact. Near the end of the operation, the investigators will calculate the same machine learning risk forecasts of major complications as TECTONICS, and enroll patients if all of the following are true: (1) No ICU admission is intended (2) ML mortality risk forecast is in top 15% of historical PACU patients.
Patients will be randomized 1:1:1 to no contact, brief contact, and full contact. The postoperative provider (PACU physician, anesthesiologist, ward clinician) will be notified before arrival of the risk forecast in the contact groups, and in the full contact group an additional set of explanatory ML outputs will be provided. The intention-to-treat principle will be followed for all analyses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 1:1:1 randomization between standard of care (no contact), postoperative contact (brief), postoperative contact (long).
| Arm | Type | Receives |
|---|---|---|
| Non-Contact | No intervention | –Participants in the non-contact group will be monitored by anesthesia control tower clinicians who will utilize AlertWatch and integrating machine-learning forecasting algorithms for adverse outcomes predictions, but who will not contact the postoperative provider unless it is clinically necessary for patient safety purposes. |
| Brief contact | Experimental | Device: Anesthesia Control Tower NotificationPACU and ward providers caring for participants in the brief contact group will be notified by Anesthesia Control Tower clinicians before arrival if the patient's forecast for mortality is in the top 15% of historical PACU patients. The notification will contain a brief summary of the patient's forecast risk of major adverse events. |
| Full contact | Experimental | Device: Anesthesia Control Tower NotificationPACU and ward providers caring for participants in the full contact group will be notified by Anesthesia Control Tower clinicians before arrival if the patient's forecast for mortality is in the top 15% of historical PACU patients. The notification will contain a report card of the patient's forecast risk of major adverse events, explanatory machine-learning outputs, most influential pre- and intraoperative data, and predicted treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Enrolled in TECTONICS Study (ID 201903026, NCT03923699), in OR randomized to contact
- workweek hours
- preoperative assessment completed
- estimated risk of mortality in top 15% of historical PACU patients
Key exclusion criteria (3 listed)
- Not enrolled in TECTONICS Study
- Operating room randomized to non-contact in TECTONICS
- Planned ICU admission
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 |
|---|---|---|
| Anesthesia Control Tower NotificationReal-time data will be monitored through the AlertWatch system as well as the electronic health record. Risk forecasts of adverse events (30 day mortality, acute kidney injury, postoperative delirium, respiratory failure), PACU length of stay, and hospital length of stay will be generated by a machine learning algorithm. Additional outputs identifying the most important predictors and their effects will be combined with risk forecasts to form a report card. | Device | Brief contact, Full contact |
Primary outcome
Unplanned ICU admission
Time frame: 7 days post-op
Admission to a "critical care" bed regardless of rationale or duration at any point in the follow up time frame. Patients who expire without transfer to ICU will be marked as positive.
2 secondary outcomes
Acute Kidney Injury
Time frame: 7 days post-op
Hospital length of stay
Time frame: 30 days post-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No. Data are a subset of TECTONICS and will be have the same sharing plan / restrictions.
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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.
Christopher R King, MD, PhD principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study of Surgery--Complications and Perioperative/Postoperative Complications, run by Washington University School of Medicine.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned ICU admission (time frame: 7 days post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.