Inpatient Mortality Prediction Algorithm Clinical Trial (... | NCT03212534

Studies
Inpatient Mortality Prediction Algorithm Clinical Trial (IMPACT)

NCT03212534

Sponsor

Dascena

Status

Withdrawn

Last Update Posted

Sep 24, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Decompensation, Heart
Decompensation; Heart, Congestive
Death

Interventions

Patient mortality prediction

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This trial did not start. No participants enrolled

Expanded Access Info

Start Date

Jul 2017Estimated

Primary Completion Date

Oct 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Jul 6, 2017

First Submission Date that Met QC Criteria

Jul 6, 2017

First Posted Date

Jul 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2021

Last Update Posted Date

Sep 24, 2021Actual

Name	Class
University of California, San Francisco	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Through the mapping of retrospective patient data into a discrete multidimensional space, a novel algorithm for homeostatic analysis, was built to make outcome predictions. In this prospective study, the ability of the algorithm to predict patient mortality and influence clinical outcomes, will be investigated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prediction Algorithm	Experimental		Other: Patient mortality prediction
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patient mortality prediction	Other	Healthcare provider is notified of patient mortality prediction.	Prediction Algorithm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In-hospital mortality		Through study completion, an average of 30 days

Secondary Outcomes

Measure	Description	Time Frame
Hospital length of stay		Through study completion, an average of 30 days

Other Outcomes

Measure	Description	Time Frame
Hospital readmission		Through study completion, an average of 30 days
ICU length of stay		Through study completion, an average of 30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adult patients admitted to the participating units will be eligible.

Exclusion Criteria:

All patients younger than 18 years of age will be excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Shimabukuro	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSF Moffit-Long Hospital		San Francisco	California	94143	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28638239	Background	Desautels T, Calvert J, Hoffman J, Mao Q, Jay M, Fletcher G, Barton C, Chettipally U, Kerem Y, Das R. Using Transfer Learning for Improved Mortality Prediction in a Data-Scarce Hospital Setting. Biomed Inform Insights. 2017 Jun 12;9:1178222617712994. doi: 10.1177/1178222617712994. eCollection 2017.
27253619	Background

ID	Term
D006333	Heart Failure
D003643	Death
D004194	Disease

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms