CreaPeriop: Perioperative Use of Serum Creatinine and Postoperative Acute Kidney Injury

• Sponsor: Careggi Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04341974
• Collaborator: (none)
• Enrollment: 423
• Location: 1
• Actual Duration (Months): 14.9
• Patients Per Site Per Month: 28.3

Study Details

Study Description

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	Phase
Surgery; Malignancy; Acute Kidney Injury; Cronich Kidney Disease	Diagnostic Test: Serum creatinine

Study Design

• 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: Jan 1, 2019
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Mar 31, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Adoption of serum creatinine as marker of acute kidney injury postoperively [3rd postoperative day]

   Number of actual patients screened postoperatively

Secondary Outcome Measures

1. Incidence of acute kidney injury [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 [12 month after surgery]

   Number of actual patients screened at the long term

3. Incidence of long term kidney dysfunction [12 month after surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda Ospedaliero Universitaria Careggi	Florence		Italy	50100

Sponsors and Collaborators

• Careggi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gianluca Villa, MD, clinical researcher, Careggi Hospital
• ClinicalTrials.gov Identifier: NCT04341974
• Other Study ID Numbers: CEAVC 13881/2018
• First Posted: Apr 10, 2020
• Last Update Posted: Apr 14, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gianluca Villa, MD, clinical researcher, Careggi Hospital: serum creatinine; kidney dysfunction
• Additional relevant MeSH terms: Kidney Diseases; Acute Kidney Injury; Wounds and Injuries

Study Results

No Results Posted as of Apr 14, 2020