- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05660174
Identification of Preoperative Parameters to Predict Acute Kidney Injury Risk Following Vascular or Digestive Surgery (SCOPING)
November 19, 2024 updated by: Centre Hospitalier Universitaire de Besancon
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
2626
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Besançon, France, 25000
- Centre Hospitalier Universitaire de Besançon
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
|---|
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Patient with a digestive surgery procedure
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Patient with a vascular surgery procedure
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Occurrence of acute kidney injury
Time Frame: 2 weeks after surgery
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Occurrence of acute kidney injury within 2 weeks after surgery, as defined by the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) criteria
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2 weeks after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Cécile Courivaud, Prof., Centre Hospitalier Universitaire de Besançon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
March 31, 2024
Study Completion (Actual)
March 31, 2024
Study Registration Dates
First Submitted
December 13, 2022
First Submitted That Met QC Criteria
December 13, 2022
First Posted (Actual)
December 21, 2022
Study Record Updates
Last Update Posted (Estimated)
November 21, 2024
Last Update Submitted That Met QC Criteria
November 19, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/699
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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