Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Predicting Acute Kidney Injury After Coronary Artery Bypass Graft

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
WonHo Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT02081261
First received: March 5, 2014
Last updated: June 14, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention
Coronary Artery Bypass Surgery
Acute Kidney Injury
Creatinine
Mortality
Procedure: Coronary artery bypass surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predicting Acute Kidney Injury After Coronary Artery Bypass Graft : a Simplified Clinical Risk Scoring Model

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Acute kidney injury diagnosis defined by KDIGO criteria [ Time Frame: during 7 days after surgery ] [ Designated as safety issue: Yes ]
    Acute kidney injury diagnosis defined by KDIGO criteria (Stage 1, 2, 3) during seven days after surgery


Secondary Outcome Measures:
  • Acute kidney injury as defined by AKIN (acute kidney injury network) criteria [ Time Frame: within 48 hours after surgery ] [ Designated as safety issue: Yes ]
    Acute kidney injury as defined by AKIN (acute kidney injury network) criteria


Enrollment: 877
Study Start Date: January 2014
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Coronary artery bypass surgery
patients who underwent coronary artery bypass surgery between 2010 and 2012 in Samsung Medical Center
Procedure: Coronary artery bypass surgery
coronary artery bypass surgery

Detailed 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.
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who underwent coronary artery bypass surgery during between 2010 and 2012 in Samsung Medical Center
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02081261

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

Responsible Party: WonHo Kim, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02081261     History of Changes
Other Study ID Numbers: 2013-12-116 
Study First Received: March 5, 2014
Last Updated: June 14, 2016
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
coronary artery bypass surgery
acute kidney injury
creatinine
mortality

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on December 05, 2016