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proMoting Effective Renoprotection in Cardiac sURgery Patients by Inhibition of SGLT-2

NCT05590143 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 784

Last updated 2025-05-18

No results posted yet for this study

Summary

Multi-centre, triple-blinded (patients, physicians, investigators), parallel-group, balanced (1:1), stratified (sex, type 2 diabetes mellitus), 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.

Conditions

Interventions

DRUG

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).

DRUG

Placebo

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

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Amsterdam UMC

    lead OTHER

Principal Investigators

  • Daniël H. van Raalte, MD, PhD · Internal Medicine Specialist

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-09
Primary Completion
2025-05-14
Completion
2025-09-30
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05590143 on ClinicalTrials.gov