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CompletedNCT04341974CreaPeriopUpdated Apr 14, 2020

Perioperative Use of Serum Creatinine and Postoperative Acute Kidney Injury

An observational study in Surgery, Malignancy and Acute Kidney Injury, sponsored by Careggi Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-14.

Sponsored by Careggi Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
423
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Surgery
  • Malignancy
  • Acute Kidney Injury
  • Cronich Kidney Disease

Keywords

  • serum creatinine
  • kidney dysfunction
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's enrollment of 423 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.

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Lead sponsor

Careggi Hospital is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients undergoing postoperative chemotherapy
  • Patients who died within 12 month after surgery
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
423 participants (actual)
Patient registry
No

Groups and cohorts

  • surgical patients

    Adult patients undergoing major elective general abdominal surgery for ontological disease

    Diagnostic Test: Serum creatinine

Interventions

  • Diagnostic testSerum 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

06

What researchers measure

Primary outcomes

  1. Adoption of serum creatinine as marker of acute kidney injury postoperively

    Number of actual patients screened postoperatively

    Time frame: 3rd postoperative day

Secondary outcomes

  1. Incidence of acute kidney injury

    Number of patients with a postoperative diagnostic increase of serum creatinine, in accordance with KDIGO guidelines

    Time frame: 3rd postoperative day

  2. Adoption of serum creatinine as marker of long term kidney dysfunction

    Number of actual patients screened at the long term

    Time frame: 12 month after surgery

  3. Incidence of long term kidney dysfunction

    Number of patients with a long term reduction in GFR greater than 10 ml/min with respect to the baseline

    Time frame: 12 month after surgery

07

Study locations

1 site
  • Azienda Ospedaliero Universitaria Careggi
    Florence, 50100, Italy
08

References and documents

Publications

  • 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. PubMed 34030728 ↗

Individual participant data

Plan to share: No — IPD will be not shared

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2019 to primary completion in Jan 2020, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 8, 2020
First posted
Apr 10, 2020
StartActual
Jan 1, 2019
Primary completionActual
Jan 1, 2020
CompletionActual
Mar 31, 2020
Last update
Apr 14, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04341974
Lead sponsor
Careggi Hospital
Responsible party
Gianluca Villa (MD, clinical researcher, Careggi Hospital) — Principal investigator
First posted
Apr 10, 2020
Start date
Jan 1, 2019
Primary completion
Jan 1, 2020
Completion
Mar 31, 2020
Last update
Apr 14, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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