Identification of Preoperative Parameters to Predict Acut... | NCT05660174

Studies
Identification of Preoperative Parameters to Predict Acute Kidney Injury Risk Following Vascular or Digestive Surgery

NCT05660174

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

Nov 21, 2024Actual

Enrollment

2,626Actual

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

Not provided

Countries

France

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

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Mar 31, 2024Actual

Completion Date

Mar 31, 2024Actual

First Submitted Date

Dec 13, 2022

First Submission Date that Met QC Criteria

Dec 13, 2022

First Posted Date

Dec 21, 2022Actual

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

Nov 19, 2024

Last Update Posted Date

Nov 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 study aims to identify the preoperative parameters associated with the risk of postoperative acute kidney injury (in particular the parameters of the SPARK score) in patients of the Besançon University Hospital who have undergone digestive or vascular surgery.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,626Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of acute kidney injury	Occurrence of acute kidney injury within 2 weeks after surgery, as defined by the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) criteria	2 weeks after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Digestive surgery or vascular surgery at Besancon University Hospital between 01/01/2019 and 31/12/2019 (retrospective) or between 01/01/2023 and 31/12/2023 (prospective)

Exclusion Criteria:

No preoperative creatinine value
Outpatient surgery
Surgery other than digestive or vascular (organ procurement surgery/nephrectomy surgery/renal transplantation)
Kidney/urinary tract surgery
Arteriovenous fistula surgery
End-stage renal disease or renal replacement therapy, except for renal transplant patients
Acute kidney injury KDIGO≥1 within 2 weeks before surgery
Patients in need of emergency surgery for ongoing haemorrhage
Legal incapacity or limited legal capacity
Subjects with no social security coverage.

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

Adult patients with a digestive or vascular surgery procedure between 01/01/2019 and 01/06/2021 (retrospective) or between 01/01/2023 and 31/12/2023 (prospective), at the University Hospital of Besançon

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cécile Courivaud, Prof.	Centre Hospitalier Universitaire de Besancon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire de Besançon		Besançon		25000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Patient with a digestive surgery procedure
Patient with a vascular surgery procedure