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

NCT02598271 | Completed

• 1 other identifier: 1223/2015
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Influence of body composition on increased baseline serum creatinine

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

  7 days

Secondary Outcomes (8)

• Influence of increased baseline serum creatinine on difference in acute kidney injury after cardiac surgery

  7 days

• Influence of neutral endopeptidase on levels of acute kidney injury

  7 days

• Influence of right ventricular function on acute kidney injury

  7 days

• Length of ICU stay

  7 days

• 30 days mortality

  30 days

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing an elective cardiac surgical intervention.

You may qualify if:

• Elective cardiac surgical intervention

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna

Vienna, 1090, Austria

Location

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MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Martin H Bernardi, Dr.

  Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 1, 2015
• First Posted: November 5, 2015
• Study Start: October 1, 2016
• Primary Completion: August 12, 2019
• Study Completion: December 30, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

AU (1)