Clinical trial

Preoperative Sodium Glucose Cotransporter 2 Inhibitors for Prevention of Postoperative Acute Kidney Injury in Cardiac Surgery Patients - a Randomized, Placebo-controlled, Multi-centre, Phase IV Clinical Trial

Name

MERCURI-2

Description

Multi-centre, triple-blinded (patients, physicians, investigators), parallel-group, balanced (1:1), stratified (male-female 50-50), randomized, controlled (placebo), phase IV clinical trial to investigate the potential of preoperative initiation (from day 1 before surgery) and perioperative continuation (until day 2 after surgery) of the SGLT2 inhibitor dapagliflozin 10 mg once daily to prevent AKI according to the KDIGO criteria (an increase in serum creatinine by 0.3 mg/dl (26.5 mmol/l) within 48 hours; or an increase in serum creatinine to 1.5 times baseline, within 7 days; or a urine output \<0.5 ml/kg/h for \>6 hours) in adult (\>18 years old) patients undergoing cardiopulmonary bypass surgery.

Trial arms

Trial start

2023-06-09

Estimated PCD

2025-11-01

Trial end

2025-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Dapagliflozin 10 MG Oral Tablet [Farxiga]

One oral tablet, once daily starting one day prior to surgery and continued until two days postoperatively (four doses).

Arms:

Intervention

Other names:

Farxiga, SGLT2i, Sodium glucose co-transporter-2 inhibitor

Placebo

One oral tablet, once daily starting one day prior to surgery and continued until two days postoperatively (four doses).

Arms:

Placebo

Size

784

Primary endpoint

AKI

Recorded daily until day 7 postoperatively or until discharge from hospital (earlier).

Eligibility criteria

Inclusion Criteria: 1. \> 18 years-old 2. Undergoing elective cardiac surgery. 3. Providing informed consent Exclusion Criteria: 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 784, 'type': 'ESTIMATED'}}

Updated at

2023-06-26

1 organization

1 product

1 drug

3 indications

Organization

Academisch Medisch Centrum - Universiteit van Amsterdam

Product

Indication

Indication

Indication

Drug