Reduction of Occurence of Acute Kidney Injury (AKI) Through Administration of Glutamine

• Status: Completed
• Trial end date: 2020-05-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Muenster
• Collaborators: Fresenius Kabi; IZKF (Interdisciplinary Centre for Clinical Research (IZKF), Muenster)

Criteria

Inclusion Criteria:

• Adult patients undergoing cardiac surgery with CPB

• Urinary [TIMP-2]*[IGFBP7] >= 0.3 4h after CPB

• Written informed consent

Exclusion Criteria:

• 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