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

NCT ID: NCT05314725

Last Updated: 2022-04-06

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-06-01

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

Detailed Description

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Conditions

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Postoperative Hyperglycemia Stress Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SGLT-2 inhibitor

Group Type EXPERIMENTAL

SGLT2 inhibitor

Intervention Type DRUG

10 days of SGLT2 inhibitor after surgery

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

10 days of placebo after surgery

Interventions

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SGLT2 inhibitor

10 days of SGLT2 inhibitor after surgery

Intervention Type DRUG

Placebo

10 days of placebo after surgery

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emilie P Palmgren Colov

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Central Contacts

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Emilie Palmgren Colov, MD

Role: CONTACT

+45 61335122

Ismail Gögenur, Dr.med

Role: CONTACT

+45 26336426

Other Identifiers

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REG-094-2021

Identifier Type: -

Identifier Source: org_study_id

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