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Completed

NCT Number: NCT02828475

CALYPSO Pilot Study: Machine Learning Based Predictions of Surgical Complications

This is a pilot study of surgical patients whose postoperative care will be augmented with a personalized risk prediction platform (CALYPSO app).

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Key information

Conditions

Complication of Surgical Procedure Postoperative Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >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

Exclusion criteria

  • Surgeries with less than 3 days of anticipated length of stay (e.g. stoma takedown)

Treatment and study plan

CALYPSO

Other

Software platform of machine-learning based predictive models of surgical complication.

Standard Care

Behavioral

Previous standard of care based on surgeon judgement alone.

Primary outcomes

  1. Thirty Day Overall Complications

    Time frame: 30 days after surgery

Secondary outcomes

  1. Thirty Day Mortality

    Time frame: 30 days after surgery

  2. Wound Complications

    Time frame: 30 days after surgery

    Includes superficial, deep, organ space infections, and wound dehiscence

  3. Cardiac Complications

    Time frame: 30 days after surgery

    includes myocardial infarction, cardiac arrest

  4. Respiratory Complications

    Time frame: 30 days after surgery

    includes unplanned reintubation, pneumonia, failure to wean from ventilator >48 hours after surgery

  5. Thrombotic complications

    Time frame: 30 days after surgery

    includes deep vein thrombosis, pulmonary emobolism

  6. Renal Complications

    Time frame: 30 days after surgery

    includes acute renal failure, renal failure requiring dialysis

  7. urinary tract infections

    Time frame: 30 days after surgery

  8. Neurologic complications

    Time frame: 30 days after surgery

    includes stroke, peripheral nerve injury, coma

  9. Septic complications

    Time frame: 30 days after surgery

    includes sepsis and septic shock

  10. Unplanned reoperation

    Time frame: 30 days after surgery

  11. unplanned readmission

    Time frame: 30 days after surgery

  12. bleeding complications

    Time frame: up to 72 hours after surgery

    needing at least 1 unit of pRBC

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Pilot Study for a Clinical Analytical Platform for Surgical Outcomes

Acronym: CALYPSO

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2016
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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