MERCURI-2

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Amsterdam UMC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Trial duration

9 Jun 2023 → 12 May 2025

Decision date (initial)

2024-06-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515260-31-00

EudraCT number

2022-002453-25

ClinicalTrials.gov

NCT05590143

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

Prevent AKI

Conditions and MedDRA coding

AKI

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. > 18 years-old
2. Undergoing elective cardiac surgery with cardio-pulmonary bypass (CPB) or off-pump coronary artery bypass surgery (OPCAB).
3. Providing informed consent

Exclusion criteria 9

1. Current treatment with SGLT2 inhibitors
2. Reduced kidney function at baseline with eGFR < 20 ml/min at time of inclusion
3. Diabetes Mellitus Type 1
4. History of diabetic keto acidosis
5. Diabetes Mellitus Type 2 with BMI<25 for people with type 2 diabetes who are using multiple daily insulin injections (both short and long-acting insulin)
6. Systolic blood pressure < 100 mmHg at time of inclusion
7. Emergency surgery, defined as in need of surgery for medical reasons < 7 days, i.e. “S1- 4” according to the Amsterdam UMC classification
8. Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
9. Known or suspected allergy to trial products or other drugs in the same class

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of AKI within 7 days after surgery, satisfying KDIGO criteria.

Secondary endpoints 14

1. Stage 3 AKI according to KDIGO criteria
2. Postoperative maximum change of eGFR compared to the baseline eGFR
3. De novo postoperative atrial fibrillation, registered on a 12-lead ECG
4. LoS-ICU: Length of Stay in the Intensive Care Unit, measured in days
5. LoS-Hos: Length of Stay in Hospital, measured in days
6. MAKE: Major Adverse Kidney Events. Composite endpoint of death, new dialysis, and worsened renal function
7. MACE: Major Adverse Cardiovascular Events. Composite endpoint of cardiovascular death, nonfatal myocardial infarction (MI), nonfatal ischaemic cerebral vascular accident (iCVA) and hospitalization for heart failure
8. Patient reported quality of recovery (QoR), according to the following three questionnaires: o DAH30: Days at Home in first 30 days o WHO-DAS 2.0: World Health Organisation Disability Assessment Schedule 2.0 o EQ5D5L: 5 level EuroQol 5D questionnaire: a standardised measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal
9. Safety outcomes: genital mycotic infections, diabetic keto-acidosis, and hypoglycaemia, in addition to incidence of postoperative complications and Serious Adverse Events (SAEs)
10. Healthcare costs and productivity costs will be objectified to weigh cost-effectiveness, using the following two questionnaires: o iPCQ: IMTA (Institute for Medical Technology Assessment) Productivity Cost Questionnaire. o IMCQ: IMTA (Institute for Medical Technology Assessment) Medical Consumption Questionnaire.
11. Peri-operative glucose measurements (routinely measured in clinical setting): average daily glucose, incidence of hypoglycaemia (blood glucose < 4 mmol/l) and hyperglycaemia (blood glucose > 10 mmol/l)
12. Peri-operative heamodynamic vital signs (routinely measured in clinical setting).
13. Postoperative of cardiac function (echocardiography and cardiac biomarkers) routinely carried out in clinical practice
14. Urine oxygenation measured with an oxygen sensor placed in the urinary catheter: mean intraoperative urine oxygenation, change from baseline and mean postoperative urine oxygenation. Frequency and duration of monitor interruptions. Correlation in time between deprived urine oxygenation and current AKI markers.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Amsterdam UMC

Sponsor organisation

Stichting Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Stichting Amsterdam UMC

Contact name

Daniël van Raalte

Public contact point

Organisation

Stichting Amsterdam UMC

Contact name

Daniël van Raalte

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications