Predicting Acute Kidney Injury After Coronary Artery Bypass Graft

Acute Kidney Injury Clinical Trial

Official title:

Predicting Acute Kidney Injury After Coronary Artery Bypass Graft : a Simplified Clinical Risk Scoring Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081261
• Other study ID #: 2013-12-116
• Status: Completed
• Phase: N/A
• First received: March 5, 2014
• Last updated: June 14, 2016
• Start date: January 2014
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Acute kidney injury after cardiac surgery is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. There have been many studies reporting risk factor of acute kidney injury after cardiac surgery, but the influence of perioperative variables related to anesthesia and perioperative medication has not been evaluated fully. The investigators attempt to evaluate the influence of perioperative clinical variables including preoperative medication, preoperative albumin level, uric acid concentration, anesthesia technique, use of hydroxyethyl starch, blood glucose level, intraoperative medication, perioperative cardiac function (systolic and diastolic function) and hemodynamic variables during surgery on the incidence of acute kidney injury after coronary artery bypass graft.

Description:

Acute kidney injury (AKI) after cardiac surgery is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. There have been many studies reporting risk factor of acute kidney injury after cardiac surgery, but the influence of perioperative variables related to anesthesia and perioperative medication has not been evaluated fully. The investigators attempt to evaluate the influence of preoperative medication, preoperative albumin level, uric acid concentration, NL ratio, anesthesia technique, use of hydroxyethyl starch, blood glucose level, intraoperative medication, perioperative cardiac function (systolic and diastolic) and hemodynamic variables during surgery on the incidence of acute kidney injury after coronary artery bypass graft. Preoperative and postoperative diastolic dysfunction may be associated with postoperative AKI. In addition, preoperative neutrophil-lymphocyte ratio (NLR) which has been reported to be a marked for systemic inflammation and was associated with prognosis in cardiac patients undergoing coronary artery bypass graft or percutaneous coronary intervention. This preoperative or immediate postoperative NLR might be able to predict AKI after coronary artery bypass surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 877
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• patients who underwent coronary artery bypass surgery during between 2010 and 2012 in Samsung Medical Center

Exclusion Criteria:

• lack of postoperative creatinine or urine output data

• patients who expired within 24hours after surgery

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Coronary Artery Bypass Surgery
• Creatinine
• Mortality

Intervention

Procedure:
• Coronary artery bypass surgery
coronary artery bypass surgery

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute kidney injury diagnosis defined by KDIGO criteria	Acute kidney injury diagnosis defined by KDIGO criteria (Stage 1, 2, 3) during seven days after surgery	during 7 days after surgery	Yes
Secondary	Acute kidney injury as defined by AKIN (acute kidney injury network) criteria	Acute kidney injury as defined by AKIN (acute kidney injury network) criteria	within 48 hours after surgery	Yes