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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03102528
Other study ID # 79/16 D
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2014
Est. completion date June 20, 2016

Study information

Verified date August 2019
Source University of Giessen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 495
Est. completion date June 20, 2016
Est. primary completion date October 31, 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Giessen

References & Publications (2)

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. Review. — View Citation

Rydén 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of acute kidney injury using full Kidney Disease Improving Global Outcomes criteria Development of AKI within 7 days. within 7 days
Secondary Renal recovery Defined as the absence of any stage of AKI by either serum creatinine or urine output criteria at hospital discharge. Within 1 month
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