Metabolic and Renal Outcomes in Cardiac Surgery Patients Receiving SGLT2 Inhibitors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-03

Study Completion Date

2023-05-26

Brief Summary

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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.

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Detailed Description

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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

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center, open-label parallel-group randomized, controlled(usual care), phase IV clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Controlled (usual care)

Standard of care, Some additional blood drawn and urine collected to compare between both groups

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention(Medication group)

Patients receive 10mg Empagliflozin(SLGT-2i) daily from 3 days prior to surgery untill 2 days post-surgery which includes day of surgery.

Group Type EXPERIMENTAL

Empagliflozin 10 MG

Intervention Type DRUG

Patients receive 10mg Empagliflozin(SLGT-2i) daily from 3 days prior to surgery untill 2 days post-surgery which includes day of surgery.

Interventions

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Empagliflozin 10 MG

Patients receive 10mg Empagliflozin(SLGT-2i) daily from 3 days prior to surgery untill 2 days post-surgery which includes day of surgery.

Intervention Type DRUG

Other Intervention Names

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Gliflozin SGLT-2i

Eligibility Criteria

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Inclusion Criteria

* 18 to 90 years old (inclusive)
* Undergoing elective cardiac surgery with cardio-pulmonary bypass.
* Providing informed consent

Exclusion Criteria

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No