Perioperative Use of Serum Creatinine and Postoperative Acute Kidney Injury (CreaPeriop)

April 10, 2020 updated by: Gianluca Villa, Careggi Hospital

Perioperative Use of Serum Creatinine and Postoperative Acute Kidney Injury: an Observational, Monocentric, Retrospective Study to Explore Physicians' Perception and Practice.

The perioperative approach adopted in a cohort of adult oncological patients undergoing major abdominal surgery will be described. In particular, the physician's attitude toward use of sCr for identification of patients at risk for PO-AKI will be described, as well as the patients who should be reassessed in the long term for progression toward CKD. The incidence and risk factors associated with PO-AKI and renal function deterioration within a year postoperatively will be also evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

423

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

  • Italy
      • Florence, Italy, 50100
        • Azienda Ospedaliero Universitaria Careggi

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients were older than 18 years, underwent surgery under general anesthesia for oncological disease who underwent major elective general abdominal surgery from November 2016 to February 2017 at the Department of Anaesthesia of Careggi Hospital

Description

Inclusion Criteria:

  • Adult patients
  • Scheduled for elective surgery
  • Surgery for oncological disease

Exclusion Criteria:

  • Patients undergoing postoperative chemotherapy
  • Patients who died within 12 month after surgery

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
surgical patients
Adult patients undergoing major elective general abdominal surgery for ontological disease
Diagnostic test: Serum creatinine
Will be described: 1) the number of patients actually screened with postoperative serum creatinine and 2) the number of patients actually screened with the same parameter at the long-term after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adoption of serum creatinine as marker of acute kidney injury postoperively
Time Frame: 3rd postoperative day
Number of actual patients screened postoperatively
3rd postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of acute kidney injury
Time Frame: 3rd postoperative day
Number of patients with a postoperative diagnostic increase of serum creatinine, in accordance with KDIGO guidelines
3rd postoperative day
Adoption of serum creatinine as marker of long term kidney dysfunction
Time Frame: 12 month after surgery
Number of actual patients screened at the long term
12 month after surgery
Incidence of long term kidney dysfunction
Time Frame: 12 month after surgery
Number of patients with a long term reduction in GFR greater than 10 ml/min with respect to the baseline
12 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Careggi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2019

Primary Completion (ACTUAL)

January 1, 2020

Study Completion (ACTUAL)

March 31, 2020

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (ACTUAL)

April 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEAVC 13881/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be not shared

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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