We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Predicting Acute Kidney Injury After Coronary Artery Bypass Graft

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: NCT02081261
Recruitment Status : Completed
First Posted : March 7, 2014
Last Update Posted : June 16, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Coronary Artery Bypass Surgery Acute Kidney Injury Creatinine Mortality Procedure: 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.

Study Design

Study Type : Observational
Actual Enrollment : 877 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predicting Acute Kidney Injury After Coronary Artery Bypass Graft : a Simplified Clinical Risk Scoring Model
Study Start Date : January 2014
Primary Completion Date : February 2016
Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

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


Secondary Outcome Measures :
  1. Acute kidney injury as defined by AKIN (acute kidney injury network) criteria [ Time Frame: within 48 hours after surgery ]
    Acute kidney injury as defined by AKIN (acute kidney injury network) criteria


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016

Keywords provided by WonHo Kim, 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