NCT04341974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
423

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

April 8, 2020

Last Update Submit

April 10, 2020

Conditions

Keywords

serum creatininekidney dysfunction

Outcome Measures

Primary Outcomes (1)

  • Adoption of serum creatinine as marker of acute kidney injury postoperively

    Number of actual patients screened postoperatively

    3rd postoperative day

Secondary Outcomes (3)

  • Incidence of acute kidney injury

    3rd postoperative day

  • Adoption of serum creatinine as marker of long term kidney dysfunction

    12 month after surgery

  • Incidence of long term kidney dysfunction

    12 month after surgery

Study Arms (1)

surgical patients

Adult patients undergoing major elective general abdominal surgery for ontological disease

Diagnostic Test: Serum creatinine

Interventions

Serum creatinineDIAGNOSTIC_TEST

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

surgical patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero Universitaria Careggi

Florence, 50100, Italy

Location

Related Publications (1)

  • Villa G, De Rosa S, Scire Calabrisotto C, Nerini A, Saitta T, Degl'Innocenti D, Paparella L, Bocciero V, Allinovi M, De Gaudio AR, Ostermann M, Romagnoli S. Perioperative use of serum creatinine and postoperative acute kidney injury: a single-centre, observational retrospective study to explore physicians' perception and practice. Perioper Med (Lond). 2021 May 25;10(1):13. doi: 10.1186/s13741-021-00184-6.

MeSH Terms

Conditions

NeoplasmsAcute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, clinical researcher

Study Record Dates

First Submitted

April 8, 2020

First Posted

April 10, 2020

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

March 31, 2020

Last Updated

April 14, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

IPD will be not shared

Locations