Impact of a treatment with angiotensin receptor blocker on outcome after acute kidney injury in patients discharged from the ICU START-or-NOT trial”.A prospective, randomized, double blinded, multicenter study

APHP0 个研究点目标入组 500 人开始时间: 2024年8月27日最近更新: 2024年9月2日

试验速览

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•-Patient between 18 and 75 years old
•-Met criteria for acute kidney injury during the ICU stay (according to the KDIGO criteria)
•- Within 30 days after ICU discharge and after their renal function has stabilized for at least 48 hours (changes in serum creatinine < 26 micromol/L or < 25%).
•- Signed informed consent
•- Patient affiliated to a Social Security System
•-Women of childbearing potential and men must agree, to use adequate and highly effective contraception, until the end of the research
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 250
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 250

•Patient treated with ACEi or ARB before ICU admission
•Patient for whom treatment with ACEi or ARB is stronglyrecommended according to the international guidelines at discharge (ie patients with congestive heart failure and persistent dyspnea with LVEF<40%, patients with diabetes mellitus AND [either albuminuria > 300 µg/g creatininuria or hypertension associated with microalbuminuria or hypertension associated with eGFR < 60 ml/min)]
•Hyperkalemia > 5 mmol/L at ICU discharge
•Systolic blood pressure <100 mmHg at ICU discharge
•Patient with severe renal failure, as defined by estimated glomerular filtration rate creatinine clearance < 15 ml/min/1.73m2), requiring renal replacement therapy at ICU discharge
•Oral route impossible.
•Breast feeding
•Patients chronically treated with Aliskiren
•Known hypersensitivity to the active substance or to one of its excipients and in particular to lactose
•Patients with a contraindication to treatment with Irbesartan
•Patients treated with diuretic, alpha-blocker, or NSAIDs

发起方