Acute Kidney Injury Clinical Trial
Official title:
Acute Kidney Injury After Cardiac Surgery - A Retrospective Single-center Study
| 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 |
| Verified date | August 2019 |
| Source | University of Giessen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Giessen |
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
| 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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