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

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05660174
Collaborator
(none)
3,000
Enrollment
14.9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Identification of Preoperative Parameters to Predict Acute Kidney Injury Risk Following Vascular or Digestive Surgery
    Anticipated Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Mar 31, 2024
    Anticipated Study Completion Date :
    Mar 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patient with a digestive surgery procedure
    Patient with a vascular surgery procedure

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of acute kidney injury [2 weeks after surgery]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Besancon

    Investigators

    • Principal Investigator: Cécile Courivaud, Prof., Centre Hospitalier Universitaire de Besançon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Besancon
    ClinicalTrials.gov Identifier:
    NCT05660174
    Other Study ID Numbers:
    • 2022/699
    First Posted:
    Dec 21, 2022
    Last Update Posted:
    Jan 4, 2023
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire de Besancon
    Vascular Surgical Procedures
    Digestive surgery
    Vascular surgery
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Wounds and Injuries

    Study Results

    No Results Posted as of Jan 4, 2023