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临床试验/ACTRN12621001102864
ACTRN12621001102864招募中2 期

Dapagliflozin in Patients with Type-2 Diabetes Admitted to Intensive Care: A Pilot Single-Centre, Feasibility Randomised Controlled Trial

Austin Health0 个研究点目标入组 40 人开始时间: 2021年8月18日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
Austin Health
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Adult aged 18 years or greater
  • Expected to be admitted to the ICU until the day after tomorrow
  • Pre-existing diagnosis of Type-2 diabetes mellitus
  • Estimated Glomerular Filtration rate (eGFR) of less than 45 ml/min/1.73m2
  • Able to take medication enterically

排除标准

  • Diagnosis of Type-1 diabetes mellitus (T1DM)
  • Documented SGLT2 inhibitor intolerance
  • Hepatic impairment with aspartate transaminase [AST] or alanine transaminase [ALT] greater than 3x the upper limit of normal [ULN]; or total bilirubin greater than 2x ULN at time of enrolment
  • No enteric route for medication administration
  • Death is deemed to be imminent or inevitable during this admission
  • Patients with diabetic ketoacidosis
  • Pre-existing urinary tract infection
  • Hypernatraemia defined as a serum sodium levels equal to or greater than 150 mmol/L at the time of screening
  • Clinician deems enrolment in the study is not in the patient’s best interests

研究者

发起方
Austin Health

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