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Acute Kidney Injury Following Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03102528
Recruitment Status : Completed
First Posted : April 5, 2017
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Faeq Husain, University of Giessen

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.

Condition or disease Intervention/treatment
Acute Kidney Injury Other: No intervention

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.

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Study Type : Observational
Actual Enrollment : 495 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Acute Kidney Injury After Cardiac Surgery - A Retrospective Single-center Study
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : October 31, 2015
Actual Study Completion Date : June 20, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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




Primary Outcome Measures :
  1. Prevalence of acute kidney injury using full Kidney Disease Improving Global Outcomes criteria [ Time Frame: within 7 days ]
    Development of AKI within 7 days.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102528


Sponsors and Collaborators
University of Giessen
Investigators
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Study Director: Claudio Ronco, MD International Renal Research Institute of Vicenza
Publications:
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Responsible Party: Faeq Husain, Senior Phyisician, University of Giessen
ClinicalTrials.gov Identifier: NCT03102528    
Other Study ID Numbers: 79/16 D
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases