Status:
COMPLETED
Reduction of Occurence of Acute Kidney Injury (AKI) Through Administration of Glutamine
Lead Sponsor:
University Hospital Muenster
Collaborating Sponsors:
Fresenius Kabi
IZKF (Interdisciplinary Centre for Clinical Research (IZKF), Muenster)
Conditions:
Cardiac Surgery
Acute Kidney Injury
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
The aim of this study is to evaluate whether the application of glutamine versus control in patients with high risk for AKI identified by biomarkers can reduce kidney damage after cardiac surgery.
Detailed Description
Cardiac surgery is characterized by an increased production of free radicals as a consequence of surgical trauma, ischemia-reperfusion injury, inflammatory response syndrome in response to the use of ...
Eligibility Criteria
Inclusion
- Adult patients undergoing cardiac surgery with CPB
- Urinary \[TIMP-2\]\*\[IGFBP7\] \>= 0.3 4h after CPB
- Written informed consent
Exclusion
- Preexisting AKI (stage 1 and higher)
- Patients with cardiac assist devices
- Pregnant women, nursing women and women of childbearing potential
- Known (Glomerulo-) Nephritis, interstitial nephritis or vasculitis
- Chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) \< 30 ml/min
- Dialysis dependent CKD
- Prior kidney transplant within the last to 12 months
- Hypersensitivity to the active substance, or to any of the excipients of the study medication
- Hepatic insufficiency
- Severe metabolic acidosis (pH \< 7.2)
- Participation in another intervention trial in the past 3 months
- Persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
- Persons held in an institution by legal or official order
Key Trial Info
Start Date :
July 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04019184
Start Date
July 18 2019
End Date
May 13 2020
Last Update
May 21 2020
Active Locations (1)
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1
University Hospital Münster
Münster, Germany, 48149