Acute Kidney InjuryPhase 4MERCURINCT06825156
Metabolic and Renal Outcomes in Cardiac Surgery Patients Receiving SGLT2 Inhibitors
A Phase 4 study testing Empagliflozin 10 MG in people with Acute Kidney Injury, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Empagliflozin 10 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Mar 2022to 26 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 90 years old (inclusive)
- Undergoing elective cardiac surgery with cardio-pulmonary bypass.
- Providing informed consent
Who cannot join
- Current treatment with SGLT2 inhibitors.
- Diabetes Mellitus Type 1
- BMI<25 for people with type 2 diabetes
- Reduced renal function at baseline with eGFR < 30 ml/min.
- Systolic blood pressure < 100 mmHg at time of inclusion.
- Emergency surgery, defined as in need of surgery for medical reasons < 7 days, i.e. "S1-4" according to the Amsterdam UMC classification.
- Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods.
- Known or suspected allergy to trial products or other drugs in the same class.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam University Medical Centre
Amsterdam-Zuidoost, North Holland, 1105 AZ
About this study
Official title: The Perioperative Renal and Metabolic Outcomes After Sodium Glucose Cotransporter 2 Inhibitor in Cardiac Surgery - an Open-label Phase IV Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Acute Kidney Injury
- Being tested
- Empagliflozin 10 MG
- Keywords
- CSA-AKI, SGLT-2i, Cardiac surgery
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Also called Gliflozin, SGLT-2i
Patients receive 10mg Empagliflozin(SLGT-2i) daily from 3 days prior to surgery untill 2 days post-surgery which includes day of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Controlled (usual care) | No intervention | Standard of care, Some additional blood drawn and urine collected to compare between both groups |
| Intervention(Medication group) | Experimental | Patients receive 10mg Empagliflozin(SLGT-2i) daily from 3 days prior to surgery untill 2 days post-surgery which includes day of surgery. Receives: Drug: Empagliflozin 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
NGAL
Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma on postoperative day 2
Measured: Day 2 post surgery
Secondary outcomes (5)
Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma.
NGAL measured in plasma
Measured: Before surgery, day of surgery, day 1+2 after surgery
Kidney Injury Molecule-1 (KIM-1) in plasma.
KIM-1 concentration measured in plasma
Measured: Before surgery, day of surgery, day 1+2 after surgery
Perioperative peak and average blood glucose levels, as measured during usual care.
Glucose levels recorded during usual routine care
Measured: During study per untill 4 days post-operatively
Blood ketone levels.
Blood ketones measured intra-operatively
Measured: During surgery at 4 measurement moments or during usual care.
Renal functioning (KDIGO criteria)
development of serum creatinine levels and urine output measured untill post-operative day 4
Measured: During study period untill post-operative day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start3 Mar 2022
- Primary completion26 May 2023
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, open-label parallel-group randomized, controlled(usual care), phase IV clinical trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Lars Ivar Pieter Snel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jeroen Hermanides, Dr., Principal investigator, Amsterdam University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825156
- Sponsor's protocol ID
- NL78156.018.21
- Acronym
- MERCURI
- Status last verified
- Feb 2025
- First submitted
- 8 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Perioperative Renal and Metabolic Outcomes After Sodium Glucose Cotransporter 2 Inhibitor in Cardiac Surgery - an Open-label Phase IV Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06825156
- Acronym / sponsor ID
- MERCURI / NL78156.018.21
- Conditions
- Acute Kidney Injury
- Keywords
- CSA-AKI, SGLT-2i, Cardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- European Commission
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, open-label parallel-group randomized, controlled(usual care), phase IV clinical trial
| Arm | Type | Receives |
|---|---|---|
| Controlled (usual care) | No intervention | –Standard of care, Some additional blood drawn and urine collected to compare between both groups |
| Intervention(Medication group) | Experimental | Drug: Empagliflozin 10 MGPatients receive 10mg Empagliflozin(SLGT-2i) daily from 3 days prior to surgery untill 2 days post-surgery which includes day of surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 90 years old (inclusive)
- Undergoing elective cardiac surgery with cardio-pulmonary bypass.
- Providing informed consent
Key exclusion criteria (8 listed)
- Current treatment with SGLT2 inhibitors.
- Diabetes Mellitus Type 1
- BMI<25 for people with type 2 diabetes
- Reduced renal function at baseline with eGFR < 30 ml/min.
- Systolic blood pressure < 100 mmHg at time of inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MGAlso: Gliflozin, SGLT-2iPatients receive 10mg Empagliflozin(SLGT-2i) daily from 3 days prior to surgery untill 2 days post-surgery which includes day of surgery. | Drug | Intervention(Medication group) |
Primary outcome
NGAL
Time frame: Day 2 post surgery
Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma on postoperative day 2
5 secondary outcomes
Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma.
Time frame: Before surgery, day of surgery, day 1+2 after surgery
Kidney Injury Molecule-1 (KIM-1) in plasma.
Time frame: Before surgery, day of surgery, day 1+2 after surgery
Perioperative peak and average blood glucose levels, as measured during usual care.
Time frame: During study per untill 4 days post-operatively
Blood ketone levels.
Time frame: During surgery at 4 measurement moments or during usual care.
Renal functioning (KDIGO criteria)
Time frame: During study period untill post-operative day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Link of the former published study protocol, National register of the Netherlands has ceased to exist.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeroen Hermanides, Dr. principal investigator
Amsterdam University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin 10 MG in people with Acute Kidney Injury, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NGAL (time frame: Day 2 post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.