MedDRA version: 26.0 Level: PT Classification code 10069339 Term: Acute kidney injury System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Trade Name: IRBESARTAN EG 150 mg
Pharmaceutical Form: Coated tablet
INN or Proposed INN: IRBESARTAN EG 150 mg
Other descriptive name: IRBESARTAN
Concentration unit: mg milligram(s)
Concentration type
Sponsors
APHP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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 =65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: 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 300 µg/g creatininuria or hypertension associated with microalbuminuria or hypertension associated with eGFR 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. Pregnancy 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the impact of the RAASi on cardiovascular and global outcome one year after ICU or acute care discharge in patients who developed an AKI during their ICU stay and totally or partially recovered.;Secondary Objective: - To evaluate the impact of RAASi initiation on renal outcome after ICU discharge - To evaluate the impact of RAASi initiation on new hospitalizations for major cardiovascular events - To evaluate the impact of RAASi initiation on potential side effect of the treatment (safety). - To identify among the patient's characteristics the factors of response to treatment, including the use of the biological collection built up at inclusion and at the end of the study ;Primary end point(s): Primary objective: To evaluate the impact of the RAASi on cardiovascular and global outcome one year after ICU or acute care discharge in patients who developed an AKI during their ICU stay and totally or partially recovered. Primary outcome: The primary endpoint of the trial is MACE (major adverse cardiovascular events), i.e. a composite outcome composed of all-cause mortality and all unscheduled hospital readmission for cardiovascular events (acute heart failure, stroke, acute coronary syndrome) during the year following ICU discharge. ;Timepoint(s) of evaluation of this end point: one year + 15 days End of research visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Albuminuria>0.3 g/day one year after ICU discharge - Occurrence of chronic kidney disease one year after ICU discharge defined as eGFR 6 mmol/L -Death - Biological collection built up at inclusion and at the end of the study ;Timepoint(s) of evaluation of this end point: Primary Endpoint assessment at one year. | — |
Countries
France
Contacts
Public ContactSafiyatou BALDE
ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS
Outcome results
None listed