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

Zealand University Hospital

Status and phase: Unknown; Phase 2

Conditions: Postoperative Hyperglycemia; Stress Hyperglycemia

Treatments: Drug: Placebo; Drug: SGLT2 inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT05314725

REG-094-2021

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

SGLT-2 inhibitor

Experimental group

Treatment:

Drug: SGLT2 inhibitor

placebo

Placebo Comparator group

Treatment:

Drug: Placebo