Postoperative Hyperglycemia, Stress Hyperglycemia
Conditions
Keywords
acute abdominal surgery, SGLT-2 inhibitor
Brief summary
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
Interventions
DRUGSGLT2 inhibitor
10 days of SGLT2 inhibitor after surgery
DRUGPlacebo
10 days of placebo after surgery
Sponsors
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time in range | from inclusion until 10 days after (or when the patient leaves the hospital) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| glucose variability | from inclusion until 10 days after (or when the patient leaves the hospital) | standard deviation divided by the mean and standard deviation |
| time with level 1 hypoglycemia | from inclusion until 10 days after (or when the patient leaves the hospital) | blood glucose 3.0-3.9mmol/l |
| time with level 2 hypoglycemia | from inclusion until 10 days after (or when the patient leaves the hospital) | blood glucose less than 3mmol/l |
| mean glucose | from inclusion until 10 days after (or when the patient leaves the hospital) | — |
| Quality of recovery-15 | every day while taking the study medication and on postoperative day 30 | Questionnaire assessing the patient's own sense of recovery after surgery |
| Nanostring | at inclusion, on day 4 of treatment and at end of treatment | changes in up- and downregulation of genes |
| time with hyperglycemia | from inclusion until 10 days after (or when the patient leaves the hospital) | blood glucose more than 10mmol/l |
Contacts
Primary ContactEmilie Palmgren Colov, MD
Backup ContactIsmail Gögenur, Dr.med
Outcome results
None listed