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

March 13, 2023 updated by: Dr. Martin Bernardi, Medical University of Vienna

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing an elective cardiac surgical intervention.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days
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
7 days
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
7 days
Length of ICU stay
Time Frame: 7 days
7 days
30 days mortality
Time Frame: 30 days
30 days
Volume status
Time Frame: 7 days
Need of crystalloid, colloid and blood products
7 days
Influence of podocin on levels of acute kidney injury
Time Frame: 7 days
Podocin will be measured out of the urine with ELISA
7 days
Influence of nephrin on levels of acute kidney injury
Time Frame: 7 days
Nephrin will be measured out of the urine with ELISA
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Martin H Bernardi, Dr., Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

August 12, 2019

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

November 1, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1223/2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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