Amsterdam University Medical Centre
Amsterdam-Zuidoost, North Holland, 1105 AZ, Netherlands
NCT Number: NCT06825156
To investigate the potential of preoperative initiation (3 days) and perioperative continuation (until day 2 after surgery) of empagliflozin(sodium glucose co transporter 2 inhibitor(SGLT-2i)) 10 mg daily to reduce the acute kidney injury marker neutrophil gelatinase-associated lipocalin (NGAL) measured in serum and urine on day 2 postoperatively in patients undergoing cardiopulmonary bypass surgery by comparing a study medication group to a control group in an open-label set-up.
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Notify Me18 year–90 year
All sexes
Interventional
Phase 4
Amsterdam-Zuidoost, North Holland, 1105 AZ, Netherlands
Adult patients scheduled for elective cardiopulmonary bypass assisted cardiothoracic surgery will be informed about the study and after receiving informed consent will be divided between two groups in an openlabel fashion:
Intevention group: Takes study medication(10mg Empagliflozin once a day in the morning) 3 days prior to surgery, day of surgery and 2 days post-surgery.
Control group: follows the usual standard of care. At time moment before surgery and before medication is taken blood and urine sample is taken. This is repeated on day of surgery, and the consecutive 2 days after surgery.
Form these samples biomakers for kidney injury will be measured and compared between groups.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Current treatment with SGLT2 inhibitors.
Patients receive 10mg Empagliflozin(SLGT-2i) daily from 3 days prior to surgery untill 2 days post-surgery which includes day of surgery.
Other names: Gliflozin, SGLT-2i
Time frame: Day 2 post surgery
Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma on postoperative day 2
Time frame: Before surgery, day of surgery, day 1+2 after surgery
NGAL measured in plasma
Time frame: Before surgery, day of surgery, day 1+2 after surgery
KIM-1 concentration measured in plasma
Time frame: During study per untill 4 days post-operatively
Glucose levels recorded during usual routine care
Time frame: During surgery at 4 measurement moments or during usual care.
Blood ketones measured intra-operatively
Time frame: During study period untill post-operative day 4
development of serum creatinine levels and urine output measured untill post-operative day 4
Time frame: During study period untill post-operative day 4
Incidence of keto-acidosis defined as combination of blood ketone concentration >3mmol/l in combination with high-anion gap acidosis ([Na+]-[Cl-]-[HCO3-]>12).
Time frame: During study period untill post-operative day 4
Incidence of Hypoglycemia during study period
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
The Perioperative Renal and Metabolic Outcomes After Sodium Glucose Cotransporter 2 Inhibitor in Cardiac Surgery - an Open-label Phase IV Randomized Controlled Trial
Acronym: MERCURI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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