Precision Medicine in Cardiovascular Surgery Associated Acute Kidney Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
The goal of this prospective observational study is to define a risk profile for cardiovascular surgery associated acute kidney injury (AKI), using clinical patient characteristics, operation parameters as well as blood and urine laboratory values.
The main question it aims to answer is:
• Does a combination of the factors mentioned above better predict patient outcome than classical factors used to date in clinical practice?
Participants of this study are adults aged 18 and above who are scheduled for elective heart or main artery surgery, and who have given written informed consent.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing elective cardiovascular surgery, such as valvular replacement surgery, with or without combined coronary artery bypass graft (CABG), or thoracic or abdominal aortic surgery.
Written informed consent obtained prior to surgery.
Disqualifiers
Patients with a kidney transplant or on renal replacement therapy
Severe liver failure, defined by the presence of encephalopathy, Factor V < 50% and INR >1.5 on preoperative blood sample (within 4 weeks).
Trial population
Patients undergoing elective cardiovascular surgery at the University Hospital Bern (Inselspital), Switzerland
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Change from baseline of serum Fetuin-A values
Measurement of serum Fetuin-A at baseline and at the various sampling time-points mentioned above.
Time frame
Baseline to day 90Secondary outcomes
1
BMI
Body mass index of participants in (kg/m2), integer: min 15 (extreme underweight), max 45 (extreme overweight)
Time frame
Baseline and day 902
eGFR
estimated glomerular filtration rate in (ml/min)
Time frame
Baseline and day 903
Proteinuria
Albumin in urine normalized to creatinine in categorized into 3 groups: 1. \<30 mg/d 2. 30-300 mg/d 3. \>300 mg/d
Time frame
Baseline and day 904
ASA score
American Society of Anesthesiology classification of physical status (1-6) 1. \- Normal health 2. \- Mild systemic disease 3. \- Severe systemic disease 4. \- Severe systemic disease that is constant threat to life 5. \- Moribund, not expected to survive 24h with or without operation 6. \- Declared brain-dead
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Insel Gruppe AG, University Hospital Bern
Lead sponsor
CSL Behring
Collaborator
Source ClinicalTrials.gov