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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02598271
Acronym
InCreAS
Enrollment
200
Registered
2015-11-05
Start date
2016-10-31
Completion date
2022-12-30
Last updated
2023-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury, Cardiac Surgery

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 description

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, such as variations in concentration related to age, sex, muscle mass and is influenced by dietary protein intake. (38) Furthermore AKI affects different complex cellular and molecular pathways. Several novel urinary biomarkers such as insulin-like growth factor-binding protein 7 (IGFBP7), tissue inhibitor of metalloproteinases-2 (TIMP-2) and neutral endopeptidase (NEP) are involved in the early phase of cell injury and predict both the development and severity of AKI and renal recovery early after cardiac surgery (39-43) 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.

Interventions

None listed

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Elective cardiac surgical intervention

Exclusion criteria

* Emergency procedures * Heart transplantation * Elective left ventricular assist device (LVAD) implantation o Pulmonary thrombendarterectomy * Declined informed consent * Age \< 18 years * Pregnant woman * Preoperative renal replacement therapy (RRT)

Design outcomes

Primary

MeasureTime frameDescription
Influence of body composition on increased baseline serum creatinine7 daysBody composition will be measured by bioelectrical impedance analysis, body weight, muscle status and nutrition status

Secondary

MeasureTime frameDescription
Influence of neutral endopeptidase on levels of acute kidney injury7 daysNeutral endopeptidase will be measured out of the urine with ELISA
Influence of right ventricular function on acute kidney injury7 daysRight ventricular function will be assessed by Tricuspid annular plane systolic excursion (TAPSE) measurements
Length of ICU stay7 days
Influence of increased baseline serum creatinine on difference in acute kidney injury after cardiac surgery7 daysAcute kidney injury will be defined by current KDIGO-Guidelines for acute kidney inujury
Volume status7 daysNeed of crystalloid, colloid and blood products
Influence of podocin on levels of acute kidney injury7 daysPodocin will be measured out of the urine with ELISA
Influence of nephrin on levels of acute kidney injury7 daysNephrin will be measured out of the urine with ELISA
30 days mortality30 days

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026