Clinical trial NCT03731117: FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU
Official title: FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Kidney Injury
Keywords: Ischemic Acute Kidney Injury
Intensive care units
AKI
ICU
FST
FUROSEMIDE STRESS TEST
RRT
Renal Replacement Therapy
sepsis
Cardio-pulmonary bypass
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-comparative, multicenter, study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Need for renal replacement therapy or death
timeFrame: Before day 7
measure: sensitivity
timeFrame: 3 hour after FST
Secondary outcomes:
measure: 6 hour urine output
timeFrame: 6 hour after FST
measure: percentage of effective renal replacement therapy
timeFrame: daily up to day 7
measure: death
timeFrame: daily up to day 7
measure: hemodynamic safety: noradrenaline dose
timeFrame: 6 hour after FST
measure: clinical safety: arterial pressure
timeFrame: 6 hour after FST
Other outcomes:
Locations:
city: Bayonne
country: France
facility: CH Cote Basque
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital Bichat
Study officials:
References: