Clinical Trial: Influence of Elevated Baseline Serum Creatinine and Body Composition on Acute Kidney Injury in Cardiac Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Influence of Elevated Baseline Serum Creatinine and Body Composition on Acute Kidney Injury in Cardiac Surgery - The InCreAS Trial

Brief Summary:

Acute kidney injury (AKI) is an infrequent but major and well - recognized complication of cardiac surgery. Recent studies demonstrated that even minimal increases in serum creatinine are associated with a rising risk of mortality, hospital length of stay, and cost. Furthermore a cut-off for baseline serum creatinine and its influence on mortality after cardiac surgery has been shown.

In this study the investigators want to test if increased bSCr is influenced by body composition. Further the investigators want to determine if the incidence of AKI is different in patients below or above the estimated cut-off. Therefore the investigators want to perform a prospective cohort analysis and will take several other body composition and nutrition parameters to test their influence on the predictive power of bSCr. Furthermore the investigators want to evaluate several novel biomarkers for AKI on their predictive effect in cardiac surgical patients.


Detailed Summary:

Acute kidney injury (AKI) is an infrequent but major and well - recognized complication of cardiac surgery (1, 2). Its incidence ranges from 1 to 30% (3). Numerous pre-, intra-, and postoperative factors have been associated with the development of AKI after cardiac surgery (3-19). Most commonly used definitions are the absolute serum creatinine level, its change within one week and/or the need for dialysis in previously undialysed patients (1, 3-5, 9-11, 19-25). In patients who are older, more obese with Type 2 diabetes and hypertension, there is increasing interest in the effects of chronic kidney disease on the cardiovascular system (26). Recent studies demonstrated that even minimal increases in serum creatinine are associated with a rising risk of mortality, hospital length of stay, and cost (27, 28). The Acute Dialysis Quality Initiative Group standardized with their Risk, Injury, Failure, Loss of Kidney Function, End-Stage Kidney Disease criteria and their modifications to the Acute Kidney Injury Network criteria the definitions of AKI (19, 29, 30). Both criteria need a baseline serum creatinine value for estimation (31).

In a recent published study (32) a cut-off for baseline serum creatinine and its influence on mortality after cardiac surgery has been shown. Under the steady-state and stable kidney function, SCr is usually produced at a relatively constant rate by the body depending on the absolute amount of muscle mass, and is a reliable and cost-effective surrogate marker for kidney function (33). SCr is strongly correlated with weight, total body water and anthropometrically estimated lean body mass (LBM) (34). Approximately half of LBM is comprised of skeletal muscle mass (35). Recent studies suggest that higher muscle mass is associated with greater longevity in people with CKD and other chronic disease states (36, 37). SCr, however, has several limitations
Sponsor: Medical University of Vienna

Current Primary Outcome: Influence of body composition on increased baseline serum creatinine [ Time Frame: 7 days ]

Body composition will be measured by bioelectrical impedance analysis, body weight, muscle status and nutrition status


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Influence of increased baseline serum creatinine on difference in acute kidney injury after cardiac surgery [ Time Frame: 7 days ]
    Acute kidney injury will be defined by current KDIGO-Guidelines for acute kidney inujury
  • Influence of neutral endopeptidase on levels of acute kidney injury [ Time Frame: 7 days ]
    Neutral endopeptidase will be measured out of the urine with ELISA
  • Influence of right ventricular function on acute kidney injury [ Time Frame: 7 days ]
    Right ventricular function will be assessed by Tricuspid annular plane systolic excursion (TAPSE) measurements
  • Length of ICU stay [ Time Frame: 7 days ]
  • 30 days mortality [ Time Frame: 30 days ]
  • Volume status [ Time Frame: 7 days ]
    Need of crystalloid, colloid and blood products


Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: November 1, 2015
Date Started: November 2015
Date Completion: June 2018
Last Updated: March 21, 2017
Last Verified: March 2017