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

NCT05660174 | Completed

• 1 other identifier: 2022/699
• Study Type: observational
• Target: 2,626
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Vascular Surgical Procedures; Digestive surgery; Vascular surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patient with a digestive surgery procedure

Patient with a vascular surgery procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Centre Hospitalier Universitaire de Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Cécile Courivaud, Prof.

  Centre Hospitalier Universitaire de Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: January 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)