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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02828475
Other study ID # Pro00072563
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2016
Est. completion date February 2017

Study information

Verified date January 2018
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date February 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
CALYPSO
Software platform of machine-learning based predictive models of surgical complication.
Behavioral:
Standard Care
Previous standard of care based on surgeon judgement alone.

Locations

Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Thirty Day Overall Complications 30 days after surgery
Secondary Thirty Day Mortality 30 days after surgery
Secondary Wound Complications Includes superficial, deep, organ space infections, and wound dehiscence 30 days after surgery
Secondary Cardiac Complications includes myocardial infarction, cardiac arrest 30 days after surgery
Secondary Respiratory Complications includes unplanned reintubation, pneumonia, failure to wean from ventilator >48 hours after surgery 30 days after surgery
Secondary Thrombotic complications includes deep vein thrombosis, pulmonary emobolism 30 days after surgery
Secondary Renal Complications includes acute renal failure, renal failure requiring dialysis 30 days after surgery
Secondary urinary tract infections 30 days after surgery
Secondary Neurologic complications includes stroke, peripheral nerve injury, coma 30 days after surgery
Secondary Septic complications includes sepsis and septic shock 30 days after surgery
Secondary Unplanned reoperation 30 days after surgery
Secondary unplanned readmission 30 days after surgery
Secondary bleeding complications needing at least 1 unit of pRBC up to 72 hours after surgery
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