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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515260-31-00
Enrollment
784
Registered
2024-06-25
Start date
2023-06-09
Completion date
2025-05-12
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AKI

Brief summary

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

Detailed description

Stage 3 AKI according to KDIGO criteria, Postoperative maximum change of eGFR compared to the baseline eGFR, De novo postoperative atrial fibrillation, registered on a 12-lead ECG, LoS-ICU: Length of Stay in the Intensive Care Unit, measured in days, LoS-Hos: Length of Stay in Hospital, measured in days, MAKE: Major Adverse Kidney Events. Composite endpoint of death, new dialysis, and worsened renal function, 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, 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, Safety outcomes: genital mycotic infections, diabetic keto-acidosis, and hypoglycaemia, in addition to incidence of postoperative complications and Serious Adverse Events (SAEs), 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., 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), Peri-operative heamodynamic vital signs (routinely measured in clinical setting)., Postoperative of cardiac function (echocardiography and cardiac biomarkers) routinely carried out in clinical practice, 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.

Interventions

DRUGForxiga 10 mg film-coated tablets

Sponsors

Stichting Amsterdam UMC
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
Stage 3 AKI according to KDIGO criteria, Postoperative maximum change of eGFR compared to the baseline eGFR, De novo postoperative atrial fibrillation, registered on a 12-lead ECG, LoS-ICU: Length of Stay in the Intensive Care Unit, measured in days, LoS-Hos: Length of Stay in Hospital, measured in days, MAKE: Major Adverse Kidney Events. Composite endpoint of death, new dialysis, and worsened renal function, 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, 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 f

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026