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

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ClinicalTrials.gov Identifier: NCT02598271
Recruitment Status : Active, not recruiting
First Posted : November 5, 2015
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Martin Bernardi, Medical University of Vienna

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.


Condition or disease
Acute Kidney Injury

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.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Influence of Elevated Baseline Serum Creatinine and Body Composition on Acute Kidney Injury in Cardiac Surgery - The InCreAS Trial
Actual Study Start Date : October 2016
Actual Primary Completion Date : August 12, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Low SCr
Patients with a serum creatinine below or equal to 1.3mg/dL
High SCr
Patients with a serum creatinine above to 1.3mg/dL



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Length of ICU stay [ Time Frame: 7 days ]
  5. 30 days mortality [ Time Frame: 30 days ]
  6. Volume status [ Time Frame: 7 days ]
    Need of crystalloid, colloid and blood products



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing an elective cardiac surgical intervention.
Criteria

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)

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): NCT02598271


Locations
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Austria
Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Martin H Bernardi, Dr. Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna
Publications:

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Responsible Party: Dr. Martin Bernardi, Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02598271    
Other Study ID Numbers: 1223/2015
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Keywords provided by Dr. Martin Bernardi, Medical University of Vienna:
Acute Kidney Injury
Cardiac Surgery
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases