NCT02828475

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

July 3, 2018

Status Verified

January 1, 2018

Enrollment Period

7 months

First QC Date

July 7, 2016

Last Update Submit

July 2, 2018

Conditions

Complication of Surgical ProcedurePostoperative Infection

Outcome Measures

Primary Outcomes (1)

  • Thirty Day Overall Complications

    30 days after surgery

Secondary Outcomes (12)

  • Thirty Day Mortality

    30 days after surgery

  • Wound Complications

    30 days after surgery

  • Cardiac Complications

    30 days after surgery

  • Respiratory Complications

    30 days after surgery

  • Thrombotic complications

    30 days after surgery

  • +7 more secondary outcomes

Study Arms (2)

CALYPSO-augmented

Patients' postoperative care will be augmented with the CALYPSO platform.

Other: CALYPSOBehavioral: Standard Care

Historical Control

Patients' postoperative care was performed using standard practice, before adopting the CALYPSO platform

Behavioral: Standard Care

Interventions

CALYPSOOTHER

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

CALYPSO-augmented
Standard CareBEHAVIORAL

Previous standard of care based on surgeon judgement alone.

CALYPSO-augmentedHistorical Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing high risk general and oncologic abdominal surgery.

You may qualify if:

  • \>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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

thiaclopridStandard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Zhifei Sun, MD

    Duke University Department of Surgery

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 11, 2016

Study Start

June 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

July 3, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)