Acute Kidney Injury Following Cardiac Surgery

August 27, 2019 updated by: Faeq Husain, University of Giessen

Acute Kidney Injury After Cardiac Surgery - A Retrospective Single-center Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 recoveryin patients undergoing cardiac surgery at San Bortolo Hospital, Italy during November 2014 - October 2015.

Study Type

Observational

Enrollment (Actual)

495

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

Inclusion Criteria:

- Adult cardiac surgery

Exclusion Criteria:

  1. 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
  2. Stage 5 chronic kidney disease (estimated glomerular filtration rate <15 ml/min/1.73 m2 or receipt of chronic dialysis)
  3. Solid organ transplant recipients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of acute kidney injury using full Kidney Disease Improving Global Outcomes criteria
Time Frame: within 7 days
Development of AKI within 7 days.
within 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal recovery
Time Frame: Within 1 month
Defined as the absence of any stage of AKI by either serum creatinine or urine output criteria at hospital discharge.
Within 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Investigators

  • Study Director: Claudio Ronco, MD, International Renal Research Institute of Vicenza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

October 31, 2015

Study Completion (Actual)

June 20, 2016

Study Registration Dates

First Submitted

March 30, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (Actual)

April 5, 2017

Study Record Updates

Last Update Posted (Actual)

August 29, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 79/16 D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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