FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU

NCT ID: NCT03731117

Last Updated: 2020-12-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2020-12-07

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FST

FUROSEMIDE STRESS TEST

Group Type: EXPERIMENTAL

Furosemide

Intervention Type: DRUG

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

Interventions

Furosemide

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

Intervention Type: DRUG

Other Intervention Names

furosemide stress test

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CH Cote Basque

Bayonne, , France

Hopital Saint Louis

Paris, , France

Hopital Bichat

Paris, , France

Countries

France

Other Identifiers

P170404J

Identifier Type: -

Identifier Source: org_study_id