Acute Kidney Injury
Conditions
Keywords
Ischemic Acute Kidney Injury, Intensive care units, AKI, ICU, FST, FUROSEMIDE STRESS TEST, RRT, Renal Replacement Therapy, sepsis, Cardio-pulmonary bypass
Brief summary
Ischemic acute tubular necrosis (ATN) is one of the main cause of acute kidney injury (AKI) in intensive care units (ICU). Sepsis and cardio-pulmonary bypass (CPB) are major providers. There is no validated tool to predict the evolution of AKI is ICU. Furosemide Stress Test (FST) may predict evolution of ATN-related AKI outside ICU in terms of progressive AKI, need for renal replacement therapy (RRT) or inpatient mortality with improved performance comparing to biomarkers. FST has not been validated in a prospective cohort in ICU in the settings of ischemic ATN. FURTHER aim to determine whether FST would be a useful tool to identify patients with slight to moderate AKI (KDIGO stage 1 and 2) who will evolve towards need for RRT following AKIKI (The Artificial Kidney Initiation in Kidney Injury ) delayed initiation criteria.
Detailed description
FURTHER will enroll consecutive patients with AKI KDIGO stage 1 or 2 associated with a sepsis or following a cardiac surgery with CPB within 72h. Patients must have achieved a hemodynamic stabilization confirmed by clinical (no need for intravenous fluids, no significant variation of noradrenaline) and non-clinical (trans-thoracic echocardiography, passive leg rise or other validated tool) assessment. Included patients will receive 1 to 1.5 mg/kg of FUROSEMIDE. Urine output will be measured for 6 hours and compensated by the same volume of intravenous crystalloids. Need for RRT will be assess at 2-hour, 6-hour and daily up to day 7, following the AKIKI-study delayed initiation arm criteria. FURTHER aim to evaluate FST in a well-defined prospective cohort of ischemic ATN-related AKI as predictor of need for RRT within a week.
Interventions
DRUGFurosemide
Furosemide (FUROSEMIDE®) 20 mg / 2ml, ampoule for injection 1 mg / kg slow intravenous injection 1.5 mg / kg if chronic exposure to diuretics in the week prior to inclusion Measurement of urine output after two and six hours. Compensation of diuresis by same volume of crystalloids over a 6-hour period
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, non-comparative, multicenter, study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 years old * Hospitalized in ICU at day of inclusion * Diagnosis of sepsis defined as proven or suspected infection and increase of the SOFA (Sequential Organ Failure Assessment) score by 2 points or more compared to basal OR Cardiothoracic surgery with CBP (Cardiopulmonary bypass) within 72 hours before inclusion * Adequate cardiac output and volemia assessed by cardiac ultrasound, venous saturation in Oxygen (ScVO2) or ΔPP * Hemodynamic stabilization : stable norepinephrine dosage (or \<20% variations) with no vascular filling during the last 3 hours * AKI stage I or II in KDIGO classification
Exclusion criteria
* Chronic Kidney Disease with glomerular filtration rate ≤ 30 ml/mn/1,73m2 * Obstructive AKI * AKI stage III in KDIGO classification * Known allergy to loop diuretics * Contraindications to Furosemide * FST not feasible within 12 hours of eligibility * Previous AKI during the same hospitalization * Pregnancy or breastfeeding women * Subject under a legal protective measure * No affiliation to a social regime or CMU
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for renal replacement therapy or death | Before day 7 | Need for renal replacement therapy will be define according to the AKIKI study (Gaudry S, Hajage D, Schortgen F, Martin-Lefevre L, Pons B, Boulet E, et al. Initiation Strategies for Renal-Replacement Therapy in the Intensive Care Unit. N Engl J Med. 2016 Jul 14;375(2):122-33). Need for RRT following AKIKI delayed initiation criteria. FST performance will be compared to the need of RRT or death. |
| sensitivity | 3 hour after FST | FST will be positive if patient is non responder : 2-hour urine output \< 200mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| death | daily up to day 7 | — |
| 6 hour urine output | 6 hour after FST | measurement of urine out |
| clinical safety: arterial pressure | 6 hour after FST | modification of systolic, diastolic or mean arterial blood pressure |
| hemodynamic safety: noradrenaline dose | 6 hour after FST | noradrenaline dose |
| percentage of effective renal replacement therapy | daily up to day 7 | Initiation of RRT |
Countries
France
Outcome results
None listed