NCT05314725Unknown2 期
Treatment With SGLT-2 Inhibitor for Postoperative Hyperglycemia in Acute Abdominal Surgery - a Randomized Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 24
- 主要终点
- time in range
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
排除标准
- •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
研究组 & 干预措施
SGLT-2 inhibitor
Experimental
干预措施: SGLT2 inhibitor (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
time in range
时间窗: 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)
次要结局
- time with level 1 hypoglycemia(from inclusion until 10 days after (or when the patient leaves the hospital))
- glucose variability(from inclusion until 10 days after (or when the patient leaves the hospital))
- mean glucose(from inclusion until 10 days after (or when the patient leaves the hospital))
- time with level 2 hypoglycemia(from inclusion until 10 days after (or when the patient leaves the hospital))
- time with hyperglycemia(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)
- Nanostring(at inclusion, on day 4 of treatment and at end of treatment)
研究者
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