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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05660174
Other study ID # 2022/699
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date March 31, 2024

Study information

Verified date March 2023
Source Centre Hospitalier Universitaire de Besancon
Contact Charline Vauchy, PhD
Phone +33381218875
Email cvauchy@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre Hospitalier Universitaire de Besançon Besançon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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