Descriptive and Risk Factors Analysis of All-cause Postop... | NCT04929886

Studies
Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Elective Surgery

NCT04929886

Sponsor

Huazhong University of Science and Technology

Status

Unknown status

Last Update Posted

Jul 26, 2021Actual

Enrollment

1,000,000Estimated

Phase

Not provided

Conditions

Postoperative Death

Interventions

Not provided

Countries

China

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

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 30, 2021Estimated

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Jun 10, 2021

First Submission Date that Met QC Criteria

Jun 10, 2021

First Posted Date

Jun 18, 2021Actual

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

Jul 21, 2021

Last Update Posted Date

Jul 26, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shanglong Yao, Clinical Professor, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Huazhong University of Science and TechnologyOTHER

Collaborators

Name	Class
National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC	OTHER
Henan Provincial People's Hospital	OTHER
Xiangya Hospital	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

The investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after elective surgery.

We identify all patients treated with elective surgery, between 2000 and 2020, within the Wuhan Union hospital and all collaborators. The surgical patient cohort will be matched with the National Death database to determine the patient's postoperative death data.

60% patients were randomly selected to the development cohort. Logistic regression analysis for prediction of postoperative death adjusted for different covariates. The model was externally validated in the remaining 40% patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative Death		The mortality within 5 years after the elective surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients Undergoing Elective Surgery

Exclusion Criteria:

Patients with incomplete electronic medical record information

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients Undergoing Emergency Surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention		Beijing	Beijing Municipality	100050	China