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

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ClinicalTrials.gov Identifier: NCT04341974
Recruitment Status : Completed
First Posted : April 10, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Gianluca Villa, Careggi Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Surgery Malignancy Acute Kidney Injury Cronich Kidney Disease Diagnostic Test: Serum creatinine

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Study Type : Observational
Actual Enrollment : 423 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Perioperative Use of Serum Creatinine and Postoperative Acute Kidney Injury: an Observational, Monocentric, Retrospective Study to Explore Physicians' Perception and Practice.
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Creatinine

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




Primary Outcome Measures :
  1. Adoption of serum creatinine as marker of acute kidney injury postoperively [ Time Frame: 3rd postoperative day ]
    Number of actual patients screened postoperatively


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341974


Locations
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Italy
Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50100
Sponsors and Collaborators
Careggi Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gianluca Villa, MD, clinical researcher, Careggi Hospital
ClinicalTrials.gov Identifier: NCT04341974    
Other Study ID Numbers: CEAVC 13881/2018
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will be not shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gianluca Villa, Careggi Hospital:
serum creatinine
kidney dysfunction
Additional relevant MeSH terms:
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Kidney Diseases
Acute Kidney Injury
Wounds and Injuries
Urologic Diseases
Renal Insufficiency