Treatment With SGLT-2 Inhibitor for Postoperative Hyperglycemia in Acute Abdominal Surgery - a Randomized Trial

Study Overview
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Brief Summary
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The aim of the study is to investigate the effect of an SGLT-2 inhibitor on postoperative hyperglycemia after acute abdominal surgery in patients without diabetes

Official Title
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Treatment With SGLT-2 Inhibitor for Postoperative Hyperglycemia in Acute Abdominal Surgery - a Randomized Trial

Conditions
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Postoperative Hyperglycemia, Stress Hyperglycemia

Intervention / Treatment
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* Drug: SGLT2 inhibitor
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Admitted to the ward after acute abdominal surgery (ASAP patient at Slagelse Hospital, OMEGA patient at Zealand University Hospital) At least two independent measurements of blood glucose above 7.7mmol/l within the first 48 hours after surgery Age of 18 to 85 Must be able to understand and sign informed content Exclusion Criteria: Patients diagnosed with diabetes mellitus Impaired kidney function (eGFR < 45mL/min) Severe liver disease (defined as transaminases above X 3 normal levels) Acute pancreatitis within the last two months or a history of chronic pancreatitis Participation in another pharmacological intervention trial Predictable poor compliance (for instance mentally impaired) Pregnancy or lactation (fertile women must have a negative serum or urine pregnancy test to participate) Allergy to study medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGLT-2 inhibitor<br> | Drug: SGLT2 inhibitor<br>* 10 days of SGLT2 inhibitor after surgery<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* 10 days of placebo after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time in range | percentage of time in range defined as blood glucose between 3.9 and 7.8mmol/l. Blood glucose will be measures continuously while taking the study medication) | from inclusion until 10 days after (or when the patient leaves the hospital) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean glucose |  | from inclusion until 10 days after (or when the patient leaves the hospital) | 
| glucose variability | standard deviation divided by the mean and standard deviation | from inclusion until 10 days after (or when the patient leaves the hospital) | 
| time with level 1 hypoglycemia | blood glucose 3.0-3.9mmol/l | from inclusion until 10 days after (or when the patient leaves the hospital) | 
| time with level 2 hypoglycemia | blood glucose less than 3mmol/l | from inclusion until 10 days after (or when the patient leaves the hospital) | 
| time with hyperglycemia | blood glucose more than 10mmol/l | from inclusion until 10 days after (or when the patient leaves the hospital) | 
| Quality of recovery-15 | Questionnaire assessing the patient's own sense of recovery after surgery | every day while taking the study medication and on postoperative day 30 | 
| Nanostring | changes in up- and downregulation of genes | at inclusion, on day 4 of treatment and at end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute abdominal surgery, SGLT-2 inhibitor