Complication of Surgical ProcedureCALYPSONCT02828475
CALYPSO Pilot Study: Machine Learning Based Predictions of Surgical Complications
An observational study of Complication of Surgical Procedure and Postoperative Infection, run by Duke University at 1 site in United States.
Trial summary
This is a pilot study of surgical patients whose postoperative care will be augmented with a personalized risk prediction platform (CALYPSO app). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Surgical Procedure, Postoperative Infection
- What is being tested?
- CALYPSO
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Feb 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing high risk general and oncologic abdominal surgery.
Who may be able to join
- >18 years of age
- Undergoing elective surgery
- Undergoing high risk colon, rectal, pancreas, gastric surgery with predicted length of stay greater or equal to 3 days
Who cannot join
- Surgeries with less than 3 days of anticipated length of stay (e.g. stoma takedown)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Pilot Study for a Clinical Analytical Platform for Surgical Outcomes
This is a pilot study of surgical patients whose postoperative care will be augmented with a personalized risk prediction platform (CALYPSO app).
Read the detailed description
CALYPSO is a software platform that uses machine learning techniques to create personalized risk predictions for postoperative complications. Individual risk factors are then linked to best-practice interventions tailored to the individual patient. The investigator aims to test the hypothesis that using CALYPSO-augmented postoperative care will reduce complication rates in patients undergoing elective general surgery. Subjects undergoing surgery will be assigned to the CALYPSO intervention in the postoperative period.
- Being tested
- CALYPSO, Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CALYPSOOther
Software platform of machine-learning based predictive models of surgical complication.
Standard CareBehavioural
Previous standard of care based on surgeon judgement alone.
| Study group | Role | What they receive |
|---|---|---|
| CALYPSO-augmented | Patients' postoperative care will be augmented with the CALYPSO platform. Receives: Other: CALYPSO; Behavioral: Standard Care | |
| Historical Control | Patients' postoperative care was performed using standard practice, before adopting the CALYPSO platform Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thirty Day Overall Complications
Measured: 30 days after surgery
Secondary outcomes (12)
Thirty Day Mortality
Measured: 30 days after surgery
Wound Complications
Includes superficial, deep, organ space infections, and wound dehiscence
Measured: 30 days after surgery
Cardiac Complications
includes myocardial infarction, cardiac arrest
Measured: 30 days after surgery
Respiratory Complications
includes unplanned reintubation, pneumonia, failure to wean from ventilator >48 hours after surgery
Measured: 30 days after surgery
Thrombotic complications
includes deep vein thrombosis, pulmonary emobolism
Measured: 30 days after surgery
Renal Complications
includes acute renal failure, renal failure requiring dialysis
Measured: 30 days after surgery
urinary tract infections
Measured: 30 days after surgery
Neurologic complications
includes stroke, peripheral nerve injury, coma
Measured: 30 days after surgery
Septic complications
includes sepsis and septic shock
Measured: 30 days after surgery
Unplanned reoperation
Measured: 30 days after surgery
unplanned readmission
Measured: 30 days after surgery
bleeding complications
needing at least 1 unit of pRBC
Measured: up to 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhifei Sun, MD, Study director, Duke University Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828475
- Sponsor's protocol ID
- Pro00072563
- Acronym
- CALYPSO
- Status last verified
- Jan 2018
- First submitted
- 7 Jul 2016
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for a Clinical Analytical Platform for Surgical Outcomes
- ClinicalTrials.gov ID
- NCT02828475
- Acronym / sponsor ID
- CALYPSO / Pro00072563
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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 a pilot study of surgical patients whose postoperative care will be augmented with a personalized risk prediction platform (CALYPSO app).
Detailed description
CALYPSO is a software platform that uses machine learning techniques to create personalized risk predictions for postoperative complications. Individual risk factors are then linked to best-practice interventions tailored to the individual patient. The investigator aims to test the hypothesis that using CALYPSO-augmented postoperative care will reduce complication rates in patients undergoing elective general surgery. Subjects undergoing surgery will be assigned to the CALYPSO intervention in the postoperative period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CALYPSO-augmented | – | Other: CALYPSO, Behavioral: Standard CarePatients' postoperative care will be augmented with the CALYPSO platform. |
| Historical Control | – | Behavioral: Standard CarePatients' postoperative care was performed using standard practice, before adopting the CALYPSO platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing high risk general and oncologic abdominal surgery.
Key inclusion criteria (3 listed)
- >18 years of age
- Undergoing elective surgery
- Undergoing high risk colon, rectal, pancreas, gastric surgery with predicted length of stay greater or equal to 3 days
Key exclusion criteria (1 listed)
- Surgeries with less than 3 days of anticipated length of stay (e.g. stoma takedown)
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 |
|---|---|---|
| CALYPSOSoftware platform of machine-learning based predictive models of surgical complication. | Other | CALYPSO-augmented |
| Standard CarePrevious standard of care based on surgeon judgement alone. | Behavioural | CALYPSO-augmented, Historical Control |
Primary outcome
Thirty Day Overall Complications
Time frame: 30 days after surgery
12 secondary outcomes
Thirty Day Mortality
Time frame: 30 days after surgery
Wound Complications
Time frame: 30 days after surgery
Cardiac Complications
Time frame: 30 days after surgery
Respiratory Complications
Time frame: 30 days after surgery
Thrombotic complications
Time frame: 30 days after surgery
Renal Complications
Time frame: 30 days after surgery
urinary tract infections
Time frame: 30 days after surgery
Neurologic complications
Time frame: 30 days after surgery
Septic complications
Time frame: 30 days after surgery
Unplanned reoperation
Time frame: 30 days after surgery
unplanned readmission
Time frame: 30 days after surgery
bleeding complications
Time frame: up to 72 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Zhifei Sun, MD study director
Duke University Department of Surgery
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 Complication of Surgical Procedure and Postoperative Infection, run by Duke University at 1 site in United States.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 3 Jul 2018. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Thirty Day Overall Complications (time frame: 30 days after surgery). 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 3 Jul 2018.