NCT03102528

Brief Summary

Acute kidney injury (AKI) occurs in approximately one-third of patients undergoing cardiac surgery (CS), and represents one of the most significant negative predictors of patient outcome in this population. The investigators sought to examine the risk factors associated with the development of AKI and renal recovery in patients undergoing cardiac surgery at San Bortolo Hospital, Italy 2014-2015.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
495

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

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

November 1, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
Last Updated

August 29, 2019

Status Verified

August 1, 2019

Enrollment Period

12 months

First QC Date

March 30, 2017

Last Update Submit

August 27, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of acute kidney injury using full Kidney Disease Improving Global Outcomes criteria

    Development of AKI within 7 days.

    within 7 days

Secondary Outcomes (1)

  • Renal recovery

    Within 1 month

Study Arms (1)

Cardiac Surgery Patients

All adult patients undergoing cardiac surgery (elective/emergent) at San Bortolo Hospital, Vicenza, Italy during November 2014 - October 2015

Other: No intervention

Interventions

No intervention

Cardiac Surgery Patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing cardiac surgery (elective, urgent and emergent; coronary artery bypass, valve replacements, combined or other surgery, with cardiopulmonary bypass) between November 2014 and October 2015 at the Division of Cardiac Surgery, San Bortolo Hospital, in Vicenza, Italy

You may qualify if:

  • \- Adult cardiac surgery

You may not qualify if:

  • Missing baseline serum creatinine (defined as a serum creatinine value within 90 prior to surgery) or missing serum creatinine within 3 days before hospital discharge
  • Stage 5 chronic kidney disease (estimated glomerular filtration rate \<15 ml/min/1.73 m2 or receipt of chronic dialysis)
  • Solid organ transplant recipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Ryden L, Sartipy U, Evans M, Holzmann MJ. Acute kidney injury after coronary artery bypass grafting and long-term risk of end-stage renal disease. Circulation. 2014 Dec 2;130(23):2005-11. doi: 10.1161/CIRCULATIONAHA.114.010622. Epub 2014 Sep 19.

    PMID: 25239439BACKGROUND
  • Pickering JW, James MT, Palmer SC. Acute kidney injury and prognosis after cardiopulmonary bypass: a meta-analysis of cohort studies. Am J Kidney Dis. 2015 Feb;65(2):283-93. doi: 10.1053/j.ajkd.2014.09.008. Epub 2014 Nov 5.

    PMID: 25445101BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

  • Claudio Ronco, MD

    International Renal Research Institute of Vicenza

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Phyisician

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 5, 2017

Study Start

November 1, 2014

Primary Completion

October 31, 2015

Study Completion

June 20, 2016

Last Updated

August 29, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share